Commission Implementing Regulation (EU) 2025/2086 of 17 October 2025 laying - 20th October 2025 - European Commission

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Official Journal EN of the European Union L series 2025/2086 20.10.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2086 of 17 October 2025 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and in vitrodiagnostic medical devices at Union level, as well as templates for those joint clinical assessments (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU(1), and in particular Article 15(1), points (b) and (c), Article 25(1), point (b), and Article 26(1) thereof,

Whereas:

(1) Pursuant to Article 7(4) of Regulation (EU) 2021/2282, the Commission, after seeking a recommendation from the Member State Coordination Group on Health Technology Assessment established under Article 3 of that Regulation (‘the Coordination Group’), is to adopt a decision, by means of an implementing act and at least every two years selecting for joint clinical assessment medical devices and in vitrodiagnostic medical devices (‘medical devices’). The Commission is to select those devices from the medical devices for which the relevant expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council(2)(‘the expert panels’) provided a scientific opinion or their views.

(2) Pursuant to Commission Implementing Regulation (EU) 2024/2699(3), the European Medicines Agency is to provide the Commission acting as secretariat of the Coordination Group (‘the HTA secretariat’) with information on all medical devices for which the expert panels provided a scientific opinion or their views no later than 15 days after the end of each quarter, pertaining to that quarter.

(3) Due to confidentiality related to the medical devices’ certification process, the adoption of the Commission decision referred to in Article 7(4) of Regulation (EU) 2021/2282 selecting medical devices for joint clinical assessment can only be launched after the certification process of the medical device is completed.

(1) OJ L 458, 22.12.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/2282/oj.

(2) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj).

(3) Commission Implementing Regulation (EU) 2024/2699 of 18 October 2024 laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitrodiagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices (OJ L, 2024/2699, 21.10.2024, ELI: http://data.europa.eu/ eli/reg_impl/2024/2699/oj).

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(4) At the same time, in order to prevent the duplication of assessments on the same medical device by the Coordination Group and by Member States’ health technology assessment authorities and bodies, it is crucial that joint clinical assessment of those devices starts as soon as the device is certified under Regulation (EU) 2017/745 or Regulation

(EU) 2017/746 of the European Parliament and of the Council(4), as applicable. Therefore, first, upon the adoption of the recommendation of the Coordination Group, the HTA secretariat should inform the health technology developers of medical devices recommended by the Coordination Group to be selected for joint clinical assessment of that recommendation, and the reasons thereof. This will also allow for adequate preparation for health technology developers for the upcoming joint clinical assessment. Second, the notified bodies designated in accordance with Regulation (EU) 2017/745 or Regulation (EU) 2017/746 (‘the notified bodies’) should be required to inform the HTA secretariat of the results of the certification process of the medical devices covered in the recommendation of the Coordination Group. Finally, upon the granting of the certificate of conformity by the notified body, the health technology developers should be invited to submit to the HTA secretariat the information necessary for the development of the assessment scope provided for in Article 8(6) of Regulation (EU) 2021/2282 (‘the assessment scope’).

(5) In order to prevent the duplication of information submission and to reduce the administrative burden, the notified bodies should not be required to provide to the HTA secretariat the information that is already duly and fully available in the European database on medical devices referred to in Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation (EU) 2017/746. The health technology developers may provide to the HTA secretariat the requested information by referring to its registration in that database.

(6) Where in specific warranted instances the Commission in its decision referred to in Article 7(4) of Regulation

(EU) 2021/2282 and adopted in accordance with the examination procedure referred to in Article 33(2) thereof selects for joint clinical assessment medical devices which were not recommended to be selected for joint clinical assessment by the Coordination Group, the health technology developers of those devices should provide information necessary for the development of the assessment scope.

(7) Due to the specificities of medical devices, some of the required evidence, such as the evidence to address some research questions of the assessment scope, may only become available after the medical device has been placed on the market. In such instances, where the joint clinical assessment of the medical device has been initiated soon after its certification under Regulation (EU) 2017/745 or Regulation (EU) 2017/746, it should be possible for the Coordination Group to assess the additional evidence by way of initiating the relevant updates of the joint clinical assessment. Joint scientific consultations can also facilitate the process of preparing relevant updates of joint clinical assessment of medical devices when the requests for joint scientific consultation meet the eligibility and selection criteria.

(8) It is necessary to ensure legal certainty for health technology developers of medical devices which the Coordination Group or its relevant subgroup considered in the preparation of its recommendation, but which it did not recommend to be selected for joint clinical assessment. Therefore, the HTA secretariat should also inform the health technology developers of such medical devices that the Coordination Group did not recommend selecting those devices for joint clinical assessment. Those medical devices may however still be selected for joint clinical assessment at a later point in time, for example when new information relating to their compliance with the selection criteria set out in Article 7(4) of Regulation (EU) 2021/2282 becomes available after their placing on the market.

(4) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitrodiagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176, ELI: http://data.europa.eu/eli/reg/ 2017/746/oj).

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(9) In order to ensure the cooperation, in particular by exchange of information, of the Coordination Group with the expert panels on the preparation and update of joint clinical assessments of medical devices, in particular as regards the application of the selection criteria listed in Article 7(4) of Regulation (EU) 2021/2282, the HTA secretariat should inform the expert panels of the recommendation of the Coordination Group. Pursuant to Article 30 of Regulation (EU) 2022/123 of the European Parliament and of the Council(5), the European Medicines Agency is acting as secretariat for those expert panels. Therefore, the exchange of information between the Coordination Group and the expert panels should be conducted via the HTA secretariat and the European Medicines Agency.

(10) In light of the tasks of the HTA secretariat set out in Regulation (EU) 2021/2282, the exchange of information with the health technology developers, notified bodies, patients, clinical experts and other relevant experts (‘individual experts’) and Member States on the preparation and update of joint clinical assessments should take place through the HTA secretariat. The HTA secretariat should ensure that all the information it receives is communicated to the Coordination Group, the subgroup of the Coordination Group on joint clinical assessments (‘the JCA Subgroup’) and assessor and co-assessor for joint clinical assessment appointed pursuant to Article 8(4) of Regulation

(EU) 2021/2282 (‘the assessor and co-assessor’), as appropriate, upon receipt of that information.

(11) To ensure the right to good administration, the health technology developer should be informed of the start of the scoping process, of the steps of the joint clinical assessment, of its update, as well as of its re-initiation under Article 10(7) of Regulation (EU) 2021/2282. The health technology developer should also be informed of the decision of the Coordination Group to include the update of the joint clinical assessment in its annual work programme, pursuant to Article 14 of Regulation (EU) 2021/2282.

(12) To ensure the effective involvement of individual experts in joint clinical assessment of medical devices, the JCA Subgroup should specify the information necessary for their identification as early as possible, whenever the Coordination Group recommends selecting a medical device for joint clinical assessment. The HTA secretariat should identify individual experts on the basis of that information.

(13) To identify individual experts with relevant in-depth specialised expertise, the HTA secretariat should be able to consult the stakeholder network established pursuant to Article 29 of Regulation (EU) 2021/2282, the European reference networks for rare and complex diseases and other relevant sources, agencies, and organisations. In order to ensure the highest scientific quality of the joint clinical assessment, in making the final selection, the JCA Subgroup should give priority to individual experts who have expertise, across several Member States, in the medical condition to be treated, therapeutic area, the type of health technology that is the subject of the joint clinical assessment or other specific expertise. These experts should be consulted during the joint clinical assessment.

(14) To ensure that individual experts take part in joint clinical assessments in an independent and transparent manner, free from conflict of interest, they should only be selected and involved in joint clinical assessments after the Commission has assessed their declared interests, in accordance with Article 5(5) of Regulation (EU) 2021/2282 and with Article 4 of Commission Implementing Regulation (EU) 2024/2745(6).

(15) In order to ensure the transparency and appropriate involvement of stakeholder organisations in its work, the JCA Subgroup may give the opportunity to patient organisations, healthcare professional organisations and clinical and learned societies to provide their input on joint clinical assessments.

(5) Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1, ELI:

http://data.europa.eu/eli/reg/2022/123/oj).

(6) Commission Implementing Regulation (EU) 2024/2745 of 25 October 2024 laying down rules for the application of Regulation

(EU) 2021/2282 of the European Parliament and of the Council as regards the management of conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups (OJ L, 2024/2745, 28.10.2024, ELI:

http://data.europa.eu/eli/reg_impl/2024/2745/oj).

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(16) To achieve the objective that, during the development of the assessment scope, Member States’ needs are translated in the lowest possible number of sets of parameters for the joint clinical assessment in terms of patient population, intervention, comparators and health outcomes, the assessor, with the assistance of the co-assessor, should prepare an assessment scope proposal that will serve as a basis for Member States to express their needs.

(17) To ensure that the assessment scope is inclusive and reflects Member States’ needs, the assessment scope proposal prepared by the assessor, with the assistance of the co-assessor, should be shared with the members of the JCA Subgroup.

(18) It should be ensured that the assessment scope is developed respecting the right to good administration and taking into account information provided by the health technology developer and input received from individual experts.

(19) Deadlines should be set for the finalisation of the assessment scope and of the draft joint clinical assessment reports by the JCA Subgroup with the aim of ensuring the timely availability of joint clinical assessment reports of medical devices. In order to maximise available resources, the assessment scope should only be finalised by the JCA Subgroup after the adoption of the Commission decision referred to in Article 7(4) of Regulation (EU) 2021/2282 selecting the medical device for joint clinical assessment.

(20) To contribute to the completeness and high quality of the dossier and the smooth conduct of the joint clinical assessment, the health technology developer should be able to request an assessment scope explanation meeting with the JCA Subgroup.

(21) In order to ensure high quality of the dossier for the joint clinical assessment and of the joint clinical assessment report, as well as to ensure the protection of confidential data for commercial reasons, deadlines should be set giving sufficient time to the health technology developer to prepare and submit that dossier and to take the following

actions: (a) provide missing information, data, analysis and other evidence as indicated in the Commission’s second request referred to in Article 10(5) of Regulation (EU) 2021/2282; (b) provide further specifications or additional information, data, analyses, or other evidence as provided for in Article 11(2) of Regulation (EU) 2021/2282;

(d) signal technical or factual inaccuracies in the draft joint clinical assessment and summary reports and any information considered as confidential.

(22) In order to ensure good administration and timely availability of joint clinical assessment reports of medical devices, deadlines should be set for the Commission’s assessment on whether the dossier submitted by the health technology developer for joint clinical assessment of the medical device meets the requirements laid down in Article 9(2), (3) and (4), of Regulation (EU) 2021/2282. In order to ensure the smooth conduct of joint clinical assessment, the Commission should consult, as appropriate, the assessor and co-assessor when carrying out the assessment.

(23) To ensure the highest scientific quality of the joint clinical assessment, individual experts should be involved in the joint clinical assessment process by being given the opportunity to provide input on the draft joint clinical assessment and summary reports.

(24) Article 11(2) of Regulation (EU) 2021/2282 requires the health technology developer to proactively inform the Coordination Group where new clinical data becomes available during the joint clinical assessment process. In order to ensure, on the one hand, the smooth conduct of the joint clinical assessment and the compliance with the deadlines for the finalisation of the joint clinical assessment report and, on the other hand, legal certainty for the health technology developer, the deadline should be set at a date in which the JCA Subgroup is to ensure that the new clinical data received by that date are considered in the draft joint clinical assessment and summary reports.

(25) In order to ensure the delivery of joint clinical assessment reports in a timely manner, deadlines should be set for finalising the revised draft joint clinical assessment and summary reports by the JCA Subgroup and for endorsing the revised draft joint clinical assessment and summary reports by the Coordination Group.

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(26) Article 10(7) and Article 14 of Regulation (EU) 2021/2282 provide respectively for the re-initation and update of a joint clinical assessment. In order to ensure the effective application of these provisions, it is necessary to adopt certain detailed procedural rules and deadlines that should apply in those instances.

(27) In order to ensure transparency, traceability and professional secrecy, as well as to contribute to the procedural compliance of joint clinical assessment reports, any documentation referred to in Regulation (EU) 2021/2282 and this Regulation should be sent in a digital format and should be exchanged during joint clinical assessments of medical devices with and between the Coordination Group, the JCA Subgroup, the HTA secretariat, the health technology developer and individual experts through the IT platform referred to in Article 30 of Regulation

(EU) 2021/2282 (‘the HTA IT platform’).

(28) In order to ensure transparency, on the one hand, and the protection of confidential data for commercial reasons, on the other hand, the joint clinical assessment and the summary reports, together with the documentation referred to in Article 30(3), points (d) and (i), of Regulation (EU) 2021/2282, should be published, after having considered the views of the JCA Subgroup as to the commercially sensitive nature of the information contained in that documentation, which the health technology developer has requested to be treated as confidential.

(29) This Regulation lays down, in accordance with Article 5(1), point (a), of Regulation (EU) 2018/1725 of the European Parliament and of the Council(7), the rules for processing of personal data for the purposes of conducting joint clinical assessments of medical devices and their updates. In particular, it specifies the personal data that may be processed, namely certain personal data relating to the individual experts involved in joint clinical assessments and their updates and certain personal data relating to the representatives appointed to the Coordination Group and the JCA Subgroup, the representatives of health technology developers and the representatives of the members of the stakeholder network established pursuant to Article 29 of Regulation (EU) 2021/2282.

(30) To ensure the processing of personal data for the purposes of conducting joint clinical assessments of medical devices and their updates, the Commission should be considered the controller of that processing within the meaning of Article 3, point (8), of Regulation (EU) 2018/1725. Any processing of personal data by the members of the Coordination Group and the JCA Subgroup and their representatives outside of the HTA IT platform is to take place in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council(8).

(31) The identity of the patient may reveal the patient’s health status in relation to the subject matter of the joint clinical assessment and should therefore be considered a special category of personal data under Article 10 of Regulation

(EU) 2018/1725. Such data should only be processed where the criteria set out in Article 10(2), point (i), of that Regulation are met. It is necessary to provide for suitable and specific measures to safeguard the rights and freedoms of the patient. In particular, no personal data of patients should be made publicly available. Moreover, under Article 5(6) of Regulation (EU) 2021/2282, the representatives appointed to the Coordination Group and the JCA Subgroup, as well as individual experts involved in joint clinical assessments and their updates, are subject to a requirement of professional secrecy, even after their duties have ceased. To ensure protection of personal data and of confidential information, it is necessary to provide that only individual experts who have signed confidentiality agreements may be involved in joint clinical assessments and their updates.

(7) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39, ELI: http://data.

europa.eu/eli/reg/2018/1725/oj).

(8) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1; ELI: http://data.europa.eu/eli/reg/2016/679/oj).

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(32) To ensure the possibility to verify whether the joint clinical assessments were conducted in the procedurally compliant manner, notably in the event of complaints or litigation, it is appropriate to provide for a retention period of personal data and for its review at regular intervals. To ensure the relevant in-depth specialised expertise in joint clinical assessment, for example, in the event where the selected individual experts step down from their roles and responsibilities, it is appropriate to provide for a retention period of personal data of individual experts not selected to take part in a joint clinical assessment.

(33) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation

(EU) 2018/1725 and delivered an opinion on 15 July 2025.

(34) The measures provided for in this Regulation are in accordance with the opinion of the committee referred to in Article 33(1) of Regulation (EU) 2021/2282,

HAS ADOPTED THIS REGULATION:

Article 1 Subject matter This Regulation lays down detailed procedural rules for joint clinical assessments of medical devices and in vitrodiagnostic medical devices (‘medical devices’) at Union level, as regards:

(a) cooperation of the Member State Coordination Group on Health Technology Assessment established under Article 3 of Regulation (EU) 2021/2282 (‘the Coordination Group’) and the Commission acting as secretariat of the Coordination Group (‘the HTA secretariat’) with the notified bodies designated in accordance with Regulation

(EU) 2017/745 or Regulation (EU) 2017/746 (‘the notified bodies’) and with the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745 (‘the expert panels’) in the form of exchange of information as regards the preparation and update of joint clinical assessments;

(b) interaction, including the timing thereof, with and between the Coordination Group, its subgroups and health technology developers, patients, clinical experts and other relevant experts (‘individual experts’) during joint clinical assessments and their updates;

(c) general procedural rules on the selection and consultation of stakeholder organisations and individual experts in joint clinical assessments;

(d) the format and templates for dossiers with information, data, analyses and other evidence to be provided by health technology developers for joint clinical assessments;

(e) the format and templates for joint clinical assessment reports and summary reports.

Article 2 Provision of information to the health technology developers on the selection of medical devices for joint clinical assessment

1. Upon the adoption by the Coordination Group of the recommendation referred to in Article 7(4) of Regulation

(EU) 2021/2282, the HTA secretariat shall take the following actions:

(a) inform the health technology developers of the medical devices for which, during the period covered in the recommendation, the relevant expert panels provided a scientific opinion or their views as referred to in Article 7(1), points (c) and (d), of Regulation (EU) 2021/2282, whether or not the Coordination Group recommended to select their medical device for joint clinical assessment. Where the Coordination Group recommended to select their medical device for joint clinical assessment, the HTA secretariat shall also inform the health technology developers of the reasons for that recommendation;

(b) invite the health technology developers of the medical devices recommended by the Coordination Group to be selected for joint clinical assessment to submit the information listed in Article 3(1) of this Regulation.

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2. Where the Commission in its decision referred to in Article 7(4) of Regulation (EU) 2021/2282 selects for joint clinical assessment medical devices not recommended to be selected by the Coordination Group, the HTA secretariat shall without delay inform the health technology developers of those medical devices thereof and shall request the health technology developers of those devices to submit the information listed in Article 3(1) of this Regulation.

The health technology developers shall provide the requested information within 7 days from whichever of the following

events happens last:

(a) granting of the certificate of conformity by the notified body;

(b) receipt of the request from the HTA secretariat.

The information listed in Article 3(1) of this Regulation may be provided by referring to its registration in the European database on medical devices referred to in Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation

(EU) 2017/746 when that information is already duly and fully available in that database.

Article 3 Provision of information by the health technology developer upon the certification of the device

1. The HTA secretariat shall invite the health technology developer of a medical device that was recommended by the Coordination Group to be selected for joint clinical assessment in the recommendation referred to in Article 7(4) of Regulation (EU) 2021/2282 to provide the HTA secretariat with the following information:

(a) the certificate of conformity referred to in Article 56 of Regulation (EU) 2017/745 or Article 51 of Regulation

(EU) 2017/746, as applicable;

(b) the instructions for use referred to in Section 23.4 of Annex I to Regulation (EU) 2017/745 or Section 20.4.1 of Annex I to Regulation (EU) 2017/746, as applicable.

2. The HTA secretariat shall invite the health technology developer to provide the information listed in paragraph 1 within 7 days from whichever of the following events happens last:

(a) granting of the certificate of conformity by the notified body;

(b) receipt of the request from the HTA secretariat referred to in Article 2(1), point (b).

3. If the subgroup of the Coordination Group on joint clinical assessments (‘the JCA Subgroup’) considers it necessary, the HTA secretariat shall invite the health technology developer to provide other information than the information listed in paragraph 1 necessary for the development of the assessment scope. The JCA Subgroup shall specify in the invitation whether the health technology developer is invited to provide that information in a meeting with the JCA Subgroup or in writing.

4. The information listed in paragraph 1 may be provided by referring to its registration in the European database on medical devices referred to in Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation (EU) 2017/746 when that information is already duly and fully available in that database.

Article 4 Exchange of information with the notified body

1. At the same time as it sends the information referred to in Article 2(1) to the health technology developer of the medical device, the HTA secretariat shall inform the notified body responsible for the conformity assessment of that device whether the Coordination Group recommended to select the medical device for joint clinical assessment. Where the Coordination Group recommended to select the medical device for joint clinical assessment, the HTA secretariat shall also inform the notified body of the reasons for that recommendation.

ELI: http://data.europa.eu/eli/reg_impl/2025/2086/oj 7/41EN OJ L, 20.10.2025 At the same time as it sends the information referred to in Article 2(2) to the health technology developer of the medical device, the HTA secretariat shall inform the notified body that granted the certificate of conformity of the selection of that device for joint clinical assessment.

2. Regarding the medical devices which the Coordination Group recommends to be selected for joint clinical assessment, the notified body shall inform the HTA secretariat of the following:

(a) the granting of the certificate of conformity to the device;

(b) the refusal of the certification of the device;

The notified body shall provide the information referred to in the first subparagraph within 7 days from any of the

following events:

(a) the granting of the certificate of conformity;

(b) the refusal of the certification;

(d) the receipt of the information from the HTA secretariat referred to in paragraph 1, if at the time of that receipt the certificate of conformity had been granted or refused or the health technology developer had withdrawn the application for certification.

3. Paragraph 2 shall not apply if the requested information is already duly and fully available in the European database on medical devices referred to in Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation (EU) 2017/746.

Article 5 Provision of information to the expert panels At the same time as it sends the information referred to in Article 2(1) to the health technology developer of the medical device, the HTA secretariat shall inform, via the European Medicines Agency, the expert panel that provided its scientific opinion or its views of the recommendation of the Coordination Group. Where the Coordination Group recommended to select the medical device for joint clinical assessment, the HTA secretariat shall also inform the expert panel of the reasons for that recommendation.

At the same time as it sends the information referred to in Article 2(2) to the health technology developer of the medical device, the HTA secretariat shall inform, via the European Medicines Agency, the expert panel that provided its scientific opinion or its views of the selection of the device for joint clinical assessment.

Article 6 Provision of information to the Coordination Group The HTA secretariat shall ensure that all the information received from the health technology developer, the notified body, individual experts and Member States related to joint clinical assessments and updates of joint clinical assessments is communicated to the Coordination Group, to the JCA Subgroup and to the assessor and co-assessor for joint clinical assessment appointed pursuant to Article 8(4) of Regulation (EU) 2021/2282 (‘the assessor and co-assessor’), as appropriate, without delay upon receipt of that information.

8/41 ELI: http://data.europa.eu/eli/reg_impl/2025/2086/ojEN OJ L, 20.10.2025 Article 7 Provision of information to the health technology developer about the start of the scoping process Upon the appointment by the JCA Subgroup of an assessor and a co-assessor, the HTA secretariat shall inform without delay the health technology developer of the start of the scoping process.

Article 8 Selection of individual experts for joint clinical assessments

1. Without due delay after the adoption by the Coordination Group of the recommendation referred to in Article 7(4) of Regulation (EU) 2021/2282, the JCA Subgroup shall specify, for each medical device, the following information:

(a) the medical condition to be treated;

(b) the therapeutic area;

(c) other specific expertise of individual experts, if needed to carry out the joint clinical assessment, including, where needed, the expertise on the type of medical device under assessment.

2. On the basis of the information listed in paragraph 1, the HTA secretariat shall identify individual experts to be consulted during the joint clinical assessment and shall compile a list of relevant individual experts, in consultation with the JCA Subgroup and the assessor and co-assessor. When compiling the list, the HTA secretariat may consult one or more

of the following sources of information:

(a) the members of the stakeholder network established pursuant to Article 29 of Regulation (EU) 2021/2282;

(b) the European reference networks for rare and complex diseases and their respective European patient advocacy groups;

(d) the national contact points designated in accordance with Article 83 of Regulation (EU) No 536/2014 of the European Parliament and of the Council(9);

(e) the European Medicines Agency.

3. Where the consultation of the sources referred to in paragraph 2 has not yielded a sufficient number of relevant individual experts, the HTA secretariat may consult the following sources for compiling a list of individual experts:

(a) other databases or directories than the ones listed in paragraph 2;

(b) members of the Coordination Group and its subgroups;

4. After the Commission has assessed, in accordance with the rules set out in Article 5(5) of Regulation (EU) 2021/2282 and Article 4 of Implementing Regulation (EU) 2024/2745, the declared interests of individual experts in the list compiled by the HTA secretariat in accordance with paragraphs 1, 2 and 3 of this Article, the HTA secretariat shall provide the JCA Subgroup with a list of available individual experts.

5. The JCA Subgroup shall make the final selection of individual experts to be consulted during the joint clinical assessment from the list of individual experts provided by the HTA secretariat in accordance with paragraph 4. In making the final selection, the JCA Subgroup shall give priority to individual experts who have expertise across a number of Member States in the medical condition, the therapeutic area or the type of health technology that is the subject of the joint clinical assessment.

(9) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1; ELI: http://data.europa.eu/eli/reg/2014/536/oj).

ELI: http://data.europa.eu/eli/reg_impl/2025/2086/oj 9/41EN OJ L, 20.10.2025 Article 9 Professional secrecy obligations of individual experts The HTA secretariat shall ensure that only individual experts who have signed a confidentiality agreement are involved in joint clinical assessments of medical devices.

Article 10 Consultation of stakeholder organisations during joint clinical assessments At specific steps and timeframes during the joint clinical assessment which the JCA Subgroup considers to be appropriate, it may give the opportunity to patient organisations, healthcare professional organisations or clinical and learned societies via the members of the stakeholder network established pursuant to Article 29 of Regulation (EU) 2021/2282 to provide input

on any of the following matters:

(a) medical condition;

(b) therapeutic area;

(d) comparator health technologies;

(e) other areas relevant for the joint clinical assessment of the medical device.

The input referred to in the first subparagraph shall be sought, and provided, via the HTA secretariat.

Article 11 Assessment scope proposal

1. The assessor, with the assistance of the co-assessor, shall prepare an assessment scope proposal with a set of the parameters for the joint clinical assessment in terms of patient population, intervention, comparators, and health outcomes, taking into account the information received pursuant to Article 3.

When preparing the assessment scope proposal, the assessor and the co-assessor shall consult the scientific consultation outcome document, if the medical device had been subject to the joint scientific consultation carried out pursuant to Articles 16 to 21 of Regulation (EU) 2021/2282. The HTA secretariat shall make that document available to the entire JCA Subgroup.

When preparing the assessment scope proposal, the assessor and the co-assessor shall have access to the relevant scientific opinion or the views of the expert panel that was shared with the HTA secretariat pursuant to Article 3(1) of Implementing Regulation (EU) 2024/2699. The HTA secretariat shall make that opinion or those views available to the entire JCA Subgroup.

At any time during the preparation of the assessment scope proposal, the assessor and co-assessor may seek, via the HTA secretariat, input on the assessment scope from the individual experts selected in accordance with Article 8. The HTA secretariat shall make that input available to the entire JCA Subgroup.

2. The HTA secretariat shall share the assessment scope proposal with the members of the JCA Subgroup. Based on the input received from the members of the JCA Subgroup, the assessor, with the assistance of the co-assessor, shall prepare a consolidated assessment scope proposal reflecting the Member States’ needs.

3. Upon the preparation by the assessor, with the assistance of the co-assessor, the consolidated assessment scope proposal, the HTA secretariat shall share that proposal with the individual experts selected in accordance with Article 8 and shall give them the opportunity to provide input.

10/41 ELI: http://data.europa.eu/eli/reg_impl/2025/2086/ojEN OJ L, 20.10.2025 Article 12 Finalisation of the assessment scope

1. The JCA Subgroup shall discuss the consolidated assessment scope proposal referred to in Article 11(2), as well as the input of individual experts referred to in Article 11(3), during an assessment scope consolidation meeting. The JCA Subgroup, via the HTA secretariat, may invite individual experts to provide their input during a dedicated part of the assessment scope consolidation meeting.

2. The JCA Subgroup shall finalise the assessment scope at the latest 60 days after the receipt of the information listed in Article 3(1), or 10 days after the adoption of the Commission decision referred to in Article 7(4) of Regulation

(EU) 2021/2282 selecting that medical device for joint clinical assessment, whichever is later.

3. The HTA secretariat shall share the assessment scope finalised by the JCA Subgroup with the health technology developer in the Commission’s first request referred to in Article 10(1) of Regulation (EU) 2021/2282.

Article 13 Assessment scope explanation meeting Upon request of the health technology developer, the HTA secretariat shall invite the health technology developer to an assessment scope explanation meeting with the JCA Subgroup. The meeting shall take place no later than 20 days from the day on which the JCA Subgroup finalises the assessment scope.

Article 14 Dossier and additional data for joint clinical assessment to be provided by the health technology developer

1. The health technology developer shall submit the dossier for the joint clinical assessment of the medical device, requested by the Commission in its first request referred to in Article 10(1) of Regulation (EU) 2021/2282, to the HTA secretariat in a digital format. The health technology developer shall submit for joint clinical assessment of the medical device, and its update, the dossier, as well as any additional information, data, analyses and other evidence in accordance with the template set out in Annex I for medical devices and in Annex II for in vitrodiagnostic medical devices.

2. The deadline to submit the dossier referred to in paragraph 1 shall be 100 days from the date of the notification of the first request to the health technology developer.

3. In justified cases, with the consent of the assessor and co-assessor, the HTA secretariat may extend the deadline referred to in paragraph 2 by maximum 30 days.

4. The health technology developer shall submit the missing information, data, analyses and other evidence indicated in the Commission’s second request referred to in Article 10(5) of Regulation (EU) 2021/2282 within 15 days from the date of

notification of the Commission’s second request to the health technology developer. However, that deadline shall be 7 days where only minor information is missing.

5. Where the assessor, with the assistance of the co-assessor, at any time during the preparation of the draft joint clinical assessment and summary reports, considers, in accordance with Article 11(2) of Regulation (EU) 2021/2282, that further specifications or clarifications or additional information, data, analyses, or other evidence are necessary, the HTA secretariat shall request the health technology developer to provide such information, data, analyses or other evidence within the deadline set by the assessor and co-assessor depending on the nature of the information requested. That deadline shall be set at minimum 7 days and maximum 30 days counting from the date of notification of the request to the health technology developer.

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6. Where the Coordination Group decides to re-initiate a joint clinical assessment pursuant to Article 10(7) of Regulation (EU) 2021/2282, the health technology developer shall submit, upon request of the HTA secretariat, updates of previously provided information, data, analyses and other evidence pursuant to Article 10(8) of Regulation

(EU) 2021/2282 within the deadline set by the assessor and co-assessor depending on the nature of the information, data, analyses or other evidence requested. That deadline shall be set at a minimum 7 days and maximum 30 days counting from the date of notification of the request to the health technology developer.

7. Once the HTA secretariat receives the dossier and further data submitted by the health technology developer pursuant to paragraphs 1, 4, 5 and 6, it shall make the dossier and these data available to the assessor, co-assessor and the JCA Subgroup at the same time.

Article 15 Commission’s confirmation of the dossier for a joint clinical assessment Within 15 working days from the date on which the health technology developer submitted the dossier, and as appropriate in consultation with the assessor and co-assessor, the Commission shall confirm whether, based on the information available at the time, the dossier for a joint clinical assessment of the medical device meets the requirements laid down in Article 9(2), (3) and (4) of Regulation (EU) 2021/2282.

Article 16 Draft joint clinical assessment and summary reports

1. The assessor, with the assistance of the co-assessor, shall prepare the draft joint clinical assessment report using the template set out in Annex III for medical devices and the template set out in Annex IV for in vitro medical devices, and summary report using the template set out in Annex V. At any time during the preparation of the draft joint clinical assessment and summary reports, the assessor and co-assessor, via the HTA secretariat, may seek input from the individual experts selected in accordance with Article 8. The HTA secretariat shall make that input available to the entire JCA Subgroup without delay.

2. The HTA secretariat shall share the draft joint clinical assessment and summary reports prepared by the assessor, with the assistance of the co-assessor, for comments with the JCA Subgroup without delay. After having considered the comments from the members of the JCA Subgroup and any input from the individual experts referred to in paragraph 1, the assessor, with the assistance of the co-assessor, shall prepare the revised draft joint clinical assessment and summary reports.

3. The HTA secretariat shall share the revised draft joint clinical assessment and summary reports with the individual experts selected in accordance with Article 8 and give them the opportunity to provide input on the revised draft joint clinical assessment and summary reports.

4. The HTA secretariat shall provide the revised draft joint clinical assessment and summary reports to the health technology developer. The health technology developer shall indicate any purely technical or factual inaccuracies and any information it considers to be confidential within 7 days from the date on which it received the revised draft joint clinical assessment and summary reports. The health technology developer shall demonstrate the commercially sensitive nature of the information it considers to be confidential.

5. Where the health technology developer submits new clinical data on its own initiative as provided for in Article 11(2) of Regulation (EU) 2021/2282, the JCA Subgroup shall make its best efforts in order that the new clinical data is considered in the joint clinical assessment report. Where the new clinical data is received no later than 60 days after the Commission’s confirmation that the dossier meets the requirements laid down in Article 9(2), (3) and (4) of Regulation (EU) 2021/2282, the JCA Subgroup shall ensure that the new clinical data is considered in the joint clinical assessment report.

12/41 ELI: http://data.europa.eu/eli/reg_impl/2025/2086/ojEN OJ L, 20.10.2025 Article 17 Finalisation of the revised draft joint clinical assessment and summary reports

1. The JCA Subgroup shall discuss the revised draft joint clinical assessment and summary reports, as well as the input

provided pursuant to Article 16(3) and (4), in a meeting. The JCA Subgroup, via the HTA secretariat, may invite individual experts in a dedicated part of the meeting discussing the relevant revised draft reports.

2. The JCA Subgroup shall finalise the revised draft joint clinical assessment and summary reports within 165 days after the Commission’s confirmation that the dossier meets the requirements laid down in Article 9(2), (3) and (4) of Regulation

(EU) 2021/2282. The JCA Subgroup shall submit the revised draft joint clinical assessment and summary reports to the Coordination Group for endorsement.

3. Where the Coordination Group re-initiates a joint clinical assessment pursuant to Article 10(7) of Regulation

(EU) 2021/2282, the JCA Subgroup shall finalise the revised draft joint clinical assessment and summary reports within 165 days from the date of re-initiation of the joint clinical assessment and shall submit them to the Coordination Group for endorsement.

4. Where the Coordination Group initiates an update of a joint clinical assessment pursuant to Article 14 of Regulation

(EU) 2021/2282, and provided that no update of the assessment scope is necessary, the JCA Subgroup shall finalise the revised draft joint clinical assessment and summary reports within 165 days from the Commission’s confirmation that the dossier meets the requirements laid down in Article 9(2), (3) and (4) of Regulation (EU) 2021/2282. The JCA Subgroup shall submit the revised updated draft joint clinical assessment and summary reports to the Coordination Group for endorsement.

Where the Coordination Group initiates an update of a joint clinical assessment pursuant to Article 14 of Regulation

(EU) 2021/2282 and provided that an update of the assessment scope is necessary, the JCA Subgroup shall finalise the revised updated draft joint clinical assessment and summary reports within 345 days from the date on which the Coordination Group initiated the update of the joint clinical assessment. The JCA Subgroup shall submit the revised updated draft joint clinical assessment and summary reports to the Coordination Group for endorsement.

5. The Coordination Group shall endorse the revised draft joint clinical assessment and summary reports within 30 days from their receipt, in accordance with Article 12(2) of Regulation (EU) 2021/2282.

Article 18 Re-initiation of joint clinical assessments

1. Where the joint clinical assessment has been discontinued pursuant to Article 10(6) of Regulation (EU) 2021/2282, and where, at the latest five months after the deadline for submission laid down in the Commission’s first request referred to in Article 10(1) of Regulation (EU) 2021/2282, a Member State shares through the HTA IT platform the information, data, analyses and other evidence that formed part of the Commission’s first request, the Commission shall assess whether, based on the information available, the requirements laid down in Article 9(2), (3) and (4), of Regulation (EU) 2021/2282 are met.

2. The Commission shall provide the results of the assessment referred to in paragraph 1 within 10 working days from the date on which the Member State shared the data referred to in paragraph 1 and as appropriate in consultation with the assessor and co-assessor. The HTA secretariat shall inform the Coordination Group and the health technology developer of the results of the Commission’s assessment.

3. Where the Coordination Group decides to re-initiate a joint clinical assessment pursuant to Article 10(7) of Regulation (EU) 2021/2282, Article 16 and Article 17(1), (3) and (5), of this Regulation shall apply.

4. The HTA secretariat shall inform the health technology developer of the re-initiation of a joint clinical assessment.

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1. Where pursuant to Article 14(1) of Regulation (EU) 2021/2282 the joint clinical assessment report specifies the need for an update and additional evidence for further assessment becomes available, the health technology developer concerned shall inform the Coordination Group of that evidence.

2. The health technology developer may also provide, on its own initiative, new relevant information, data, analyses and other evidence to the Coordination Group in cases where the joint clinical assessment report did not specify the need for an update. Based on this information, data, analyses and evidence, the Coordination Group may decide to include an update of the joint clinical assessment in its annual work programme.

3. The HTA secretariat shall inform the health technology developer of the decision of the Coordination Group on the inclusion of the update of the joint clinical assessment in the annual work programme of the Coordination Group.

4. Where possible, the JCA Subgroup shall appoint the same assessor and co-assessor to conduct the update of the joint clinical assessment as the assessors in the initial joint clinical assessment and shall involve in the update the individual experts who were asked to provide input for the initial joint clinical assessment. Upon the appointment by the JCA Subgroup of the assessor and the co-assessor to conduct the update, the HTA Secretariat shall inform the health technology developer about the initiation of an update of the joint clinical assessment.

5. The JCA Subgroup shall decide whether an update of the assessment scope is necessary. If the JCA Subgroup concludes that an update of the assessment scope is not necessary, the HTA secretariat shall inform the health technology developer of the maintained assessment scope and shall request the submission of the updated dossier for the joint clinical assessment of the medical device. The deadlines referred to in Article 14(6) shall apply to that request. Article 15 shall apply to the confirmation by the Commission with the necessary modifications. Article 16 and Article 17(1), (4) and (5), shall apply to the preparation and finalisation of the updated draft joint clinical assessment and summary reports.

6. If the JCA Subgroup concludes that an update of the assessment scope is necessary, the HTA secretariat shall share the initial assessment scope for the purposes of collecting the information on Member States’ needs. Based on the input received from the Member States, the assessor, with the assistance of the co-assessor, shall prepare an updated assessment scope proposal reflecting the Member States’ needs. Article 11(2) and (3), and Article 12(1) shall apply to the input on the updated assessment scope proposal with the necessary modifications. The JCA Subgroup shall finalise the updated assessment scope within 60 days from the initiation of the update.

7. If the assessment scope is updated, the HTA secretariat shall inform the health technology developer of the updated assessment scope and shall request the submission of the updated dossier for the joint clinical assessment of the medical device. Article 14(1) to (5) and (7) and Article 15 shall apply to the submission of the updated dossier for the joint clinical assessment and its confirmation by the Commission with the necessary modifications.

8. If the assessment report is updated and if the Commission confirms that the requirements laid down in Article 9(2),

(3) and (4), of Regulation (EU) 2021/2282 are met, the assessor, with the assistance of the co-assessor, shall prepare an updated draft joint clinical assessment and updated draft summary reports. Article 16 and Article 17(1), (4) and (5) shall apply to the preparation and finalisation of the updated draft joint clinical assessment and summary reports with the necessary modifications.

9. When deciding whether an update of the assessment scope is necessary pursuant to paragraph 5 of this Article, the JCA Subgroup shall consult the scientific consultation outcome document, if the medical device had been subject to the joint scientific consultation carried out pursuant to Articles 16 to 21 of Regulation (EU) 2021/2282. The HTA secretariat shall make that document available to the JCA Subgroup.

14/41 ELI: http://data.europa.eu/eli/reg_impl/2025/2086/ojEN OJ L, 20.10.2025 Article 20 Correspondence during joint clinical assessments Any documentation referred to in Regulation (EU) 2021/2282 and in this Regulation shall be sent in a digital format and shall be exchanged with and between the Coordination Group, the JCA Subgroup, the HTA secretariat, the health technology developer and individual experts during joint clinical assessments and updates of joint clinical assessments through the HTA IT platform.

Article 21 Confidentiality requests

1. The Commission shall publish the joint clinical assessment and summary reports as referred to in Article 12(4) of Regulation (EU) 2021/2282, together with other documentation listed in Article 30(3), points (d) and (i), thereof, after having considered the views of the JCA Subgroup as to the commercially sensitive nature of the information contained in that documentation, which the health technology developer has requested to be treated as confidential.

2. Before publishing the documentation referred to in paragraph 1, the Commission shall provide the health technology developer with the list of information that it does not consider as confidential, having assessed the justification provided by the health technology developer and considered the views of the JCA Subgroup. It shall inform the health technology developer of the right to appeal the refusal to redact that information.

Article 22 Personal data processing

1. The Commission shall be the controller of the processing of personal data collected for the purpose of conducting joint clinical assessments of medical devices and their updates under this Regulation.

2. The categories of personal data necessary for the purpose referred to in paragraph 1 shall be the following:

(a) the identity, email address and affiliation of the representatives appointed to the Coordination Group and the JCA Subgroup;

(b) the identity and email address of individual experts in any of the following cases:

(1) they are identified as relevant for joint clinical assessment or its update;

(2) they are selected to be consulted in a joint clinical assessment or its update;

(3) they are consulted in a joint clinical assessment or its update;

(c) the identity, email address and affiliation of the representatives of health technology developers of medical devices;

(d) the identity, email address and affiliation of the representatives of the members of the stakeholder network established pursuant to Article 29 of Regulation (EU) 2021/2282.

3. The representatives appointed to the Coordination Group and the JCA Subgroup shall have access only to the parts of the secure system of the HTA IT platform relevant for the performance of their tasks. Representatives may collaborate, through the HTA IT platform, with other representatives appointed to the Coordination Group, or the JCA Subgroup to which they belong, for the purposes of conducting joint clinical assessments of medical devices and their updates.

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4. The personal data of patients involved in joint clinical assessments and their updates shall not be published.

5. The Commission shall keep the personal data listed in paragraph 2 only for as long as necessary for the purpose referred to in paragraph 1 and no longer than 15 years after the date on which the data subject no longer participates in joint clinical assessment. The Commission shall review the necessity of storing the personal data every 2 years.

The Commission shall keep the personal data of individual experts not selected to take part in a joint clinical assessment only for as long as necessary in order to ensure the relevant in-depth specialised expertise in joint clinical assessment and no longer than 3 years after the date on which the Commission received this data.

Article 23 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 17 October 2025.

For the Commission The President Ursula VON DER LEYEN 16/41 ELI: http://data.europa.eu/eli/reg_impl/2025/2086/ojEN OJ L, 20.10.2025 ANNEX I TEMPLATE FOR THE DOSSIER FOR THE JOINT CLINICAL ASSESSMENT OF A MEDICAL DEVICE The provision of information, data, analysis and other evidence in the dossier shall follow international standards of evidence-based medicine. The health technology developer shall consult, if available, the methodological guidance adopted by the Member State Coordination Group on Health Technology Assessment (‘Coordination Group’) under Article 3(7), point (d), of Regulation (EU) 2021/2282 where applicable and describe and justify any deviations from that guidance. The information requested in the dossier template shall be provided in a clear format, preferably in tabular format when possible.

Revision history Unnecessary lines shall be deleted. If needed, lines may be added.

Submission Commission’s check Version Document Legal reference date date V0.1 Initial dossier Article 10(2) of Regulation

(EU) 2021/2282 V0.2 (Updated dossier following Article 10(5) of Regulation Commission’s second (EU) 2021/2282 request) V0.3 (Updated dossier following Article 11(2) of Regulation N/A assessors’ request for (EU) 2021/2282 further specifications, clarifications or additional information) V0.4 (Updated dossier following Article 10(8) of Regulation N/A re-initiation of a JCA) (EU) 2021/2282 V0.5 (Dossier with the HTD’s Article 11(5) of Regulation N/A indications and (EU) 2021/2282 justification of confidential information) V1.0 Dossier for publication Article 21 of Implementing N/A (without confidential Regulation (EU) 2025/2086 information) V1.0.1 (Updated dossier where Article 19(1) of N/A the joint clinical Implementing Regulation assessment report specifies (EU) 2025/2086 the need for an update and additional evidence for further assessment becomes available) V1.0.2 (Updated dossier provided Article 19(2) of N/A on the initiative of the Implementing Regulation HTD where additional (EU) 2025/2086 evidence for further assessment becomes available)

ELI: http://data.europa.eu/eli/reg_impl/2025/2086/oj 17/41EN OJ L, 20.10.2025 Submission Commission’s check Version Document Legal reference date date V1.0.3 (Updated dossier following Article 19(5) of the initiation of an update Implementing Regulation of a JCA – update of the (EU) 2025/2086 assessment scope not needed) V1.0.4 (Updated dossier following Article 19(6) of the initiation of an update Implementing Regulation of a JCA – update of the (EU) 2025/2086 assessment scope needed) V1.0.5 (Updated dossier following Article 11(5) of Regulation N/A the initiation of an update (EU) 2021/2282 of a JCA with the HTD’s indications and justification of confidential information) V2.0 (Dossier for publication Article 21 of Implementing N/A following the finalisation Regulation (EU) 2025/2086 of an update of a JCA (without confidential information)) List of abbreviations The following list presents suggestions for abbreviations. It may be adapted to the dossier. Supplementary lines may be added, if needed.

Abbreviation Meaning CER Clinical evaluation report as referred to in Article 61(12) of Regulation (EU) 2017/745 and part A of Annex XIV to Regulation (EU) 2017/745 CIP Clinical investigation plan as referred to in Section 3 Chapter II of Annex XV to Regulation

(EU) 2017/745 CIR Clinical investigation report as referred to in Section 7 Chapter III of Annex XV to Regulation

(EU) 2017/745 EEA European Economic Area HTA Health Technology Assessment HTD Health Technology Developer JCA Joint Clinical Assessment JSC Joint Scientific Consultation MD Medical Device PMCF Post-Market Clinical Follow-up

PICO A set of parameters for the joint clinical assessment in terms of: Patient Population – Intervention(s) – Comparator(s) – Health Outcomes 18/41 ELI: http://data.europa.eu/eli/reg_impl/2025/2086/ojEN OJ L, 20.10.2025 Table of Contents List of tables

1. Overview

1.1. Information about the medical device under assessment (‘the medical device’) and the HTD

This section shall provide:

(a) the trade name of the medical device;

(b) the corporate name and permanent address of the HTD submitting the dossier for the JCA. In case the manufacturer to which the certificate of conformity for the medical device was issued is different from the HTD submitting the dossier, the corporate name and address of both the manufacturer and the HTD shall be specified.

1.2. Previous assessments under Regulation (EU) 2021/2282 (point e of Annex II.1 to Regulation (EU) 2021/2282) This section shall indicate whether the medical device has been subject to a previous assessment under Regulation

(EU) 2021/2282, either for the same medical indication or for another medical indication. If the answer is positive, the section shall provide the medical indication, the date and the reference of the previous JCA report.

1.3. Executive summary (points j to m of Annex II.1 to Regulation (EU) 2021/2282) This section shall provide a concise executive summary of the dossier focusing on the assessment scope as set out pursuant to Article 8(6) of Regulation (EU) 2021/2282 and shared with the HTD in the Commission’s first request referred to in Article 10(1) of Regulation (EU) 2021/2282 (‘the assessment scope’). The executive summary shall

include:

(a) the identification of any PICO(s) for which data was not submitted;

(b) a summary of the data analysed (e.g. effect measures with statistical precision for each outcome) with regard to the assessment scope, indicating whether the results were based on direct or indirect evidence. The data shall be

provided for each PICO separately;

2. Background

2.1. Characterisation of the medical condition to be treated, prevented or diagnosed (point h of Annex II.1 to Regulation

(EU) 2021/2282)

2.1.1.Overview of the medical condition

This section shall:

(a) describe the medical condition which the medical device intends to treat, monitor, alleviate, compensate, prevent or diagnose, including criteria for its diagnosis, if available, using a standardised code such as the International Statistical Classification of Diseases and Related Health Problems (‘ICD’) code or the Diagnostic and Statistical Manual of Mental Disorders (‘DSM’) code and the version of the code;

(b) where relevant, describe the main stages and/or subtypes of the medical condition;

(c) include any prognostic factors that may affect the course of the disease or medical condition and the prognosis of the medical condition without the new treatment;

(d) present an estimate of the most recent prevalence and/or incidence for the medical condition in the EEA States and, where relevant, describe any profound differences between these EEA States;

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(e) describe the symptoms and burden of the medical condition for patients, including aspects such as pain, disability, psychosocial issues, and other determinants of morbidity and quality of life from a patient’s perspective;

(f) for medical conditions that result in disability and/or a need for a family caregiver, and for treatments that result in major organisational changes to the healthcare system (e.g., due to manufacturing constraints) or major

associated procedures: briefly describe the organisational and societal impact of the medical condition and its treatment, giving some context for interpretation of outcomes.

References for the statements shall be provided. Full texts of references shall be provided in Appendix D.1.

2.1.2.Characterisation of the target patient population In case the target population is more specific than the overall medical condition, this section shall:

(a) name and describe the default target patient population(s) for the indication(s), in line with the intended purpose specified in the product certificate and summary of safety and clinical performance of the device (where relevant);

(b) describe and justify the proposed position of the target patient population(s) in the patient pathway of care;

(d) describe any patient sub-populations, including the criteria for their identification, if specifically defined in the assessment scope, and further patient sub-populations, if appropriate;

(e) describe the natural progression of the medical condition (by patient sub-population, if appropriate).

References for the statements shall be provided. Full texts of references shall be provided in Appendix D.1.

2.1.3.Clinical management of the medical condition

This section shall:

(a) describe the care pathway for the medical condition, which the medical device intends to treat, monitor, alleviate, compensate, prevent or diagnose where relevant, for different stages and/or subtypes of the disease or medical condition or patient sub-populations, with diagrams of the care pathway(s) that include comparator(s);

(b) where care pathways vary substantially between the EEA States, briefly describe these variations in care;

(c) include a list of relevant clinical guidelines at the European level, e.g., by European medical associations or societies, if available.

References for the statements shall be provided. Full texts of references shall be provided in Appendix D.1.

2.2. Characterisation of the medical device (point i of Annex II.1 to Regulation (EU) 2021/2282)

2.2.1.Characteristics of the medical device This section shall describe the characteristics of the medical device and in particular, report the following

information:

(a) model(s) of the medical device including description of the different references / reference number(s) / software version;

(b) Basic UDI-DI(s) referred to in the current certificate of conformity;

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(d) European Nomenclature on Medical Devices (EMDN)(1)description (most granular level, as relevant);

(e) intended purpose;

(f) brief description of the medical device including its constituents;

(g) mode(s) of action;

(h) frequency and duration of use;

(i) claimed device lifetime;

(j) when previous versions of the medical device are available, description of the main changes made to these different versions;

(k) if applicable, specific description for the connected technology;

(l) for medical devices with an embedded decision-making system based on machine learning and artificial intelligence processes, description of the functions built-in or evolving using these technologies.

References for the statements shall be provided. Full texts of references shall be provided in Appendix D.1.

2.2.2.Summary of the main requirements for use

This section shall:

(a) describe procedures including surgical procedures, and services associated with the use of the medical device;

(b) describe organisational aspects associated with the use of the medical device, in particular any specifically qualified personnel, training of users, specific equipment and special facilities required to use the medical device, including any specific tests or investigations required. Where such equipment has been fully described in Section 2.2.1, the current section shall refer to the above description and state that there are no additional requirements;

These characteristics shall be specified by sub-population, if appropriate.

References for the statements shall be provided. Full texts of references shall be provided in Appendix D.1.

2.2.3.Regulatory status of the medical device

This section shall:

(a) provide the regulatory status of the medical device in the indication considered for this JCA in Australia, Canada, China, Japan, United Kingdom, United States of America and other countries if relevant;

(b) indicate the date on which the medical device was placed on the EU market, where applicable;

(d) specify if the medical device has been certified under Regulation (EU) 2017/745 for other indications than the indication considered for this JCA.

References for the statements shall be provided. Full texts of references shall be provided in Appendix D.1.

(1) European Medical Device Nomenclature (EMDN) - EUDAMED.

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2.3. JSC related to the JCA (point g of Annex II.1 to Regulation (EU) 2021/2282) Where the medical device has been subject to a JSC under of Regulation (EU) 2021/2282, this section shall explain any deviation from the recommended proposition for evidence generation. The recommendations shall be documented in Appendix D.8.

3. Assessment scope (point j of Annex II.1 to Regulation (EU) 2021/2282)

This section shall: — reproduce the assessment scope in the format shared with the HTD in the Commission’s first request referred to in Article 10(1) of Regulation (EU) 2021/2282; — clearly identify any PICO(s), for which data is not submitted and explain the reasons for this omission.

4. Description of methods used in the development of the content of the dossier (point k of Annex II.1 to Regulation

(EU) 2021/2282) This section shall describe the methods used in the development of the content of the dossier. The HTD shall consult, if available, the methodological guidance adopted by the Coordination Group pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282.

4.1. Criteria for selecting studies for JCA This section shall specify the inclusion and exclusion criteria for studies to be considered for this JCA based on the assessment scope. The HTD shall consult, if available, the methodological guidance adopted by the Coordination Group pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282. The specification for inclusion and exclusion criteria shall be provided for each PICO, as appropriate.

4.2. Information retrieval and selection of relevant studies

4.2.1.Information retrieval The HTD shall explain the conduct of the information retrieval process with the objective of identifying the evidence to be used for the preparation of the dossier, systematically considering the following sources of information:

(a) clinical efficacy and safety studies and where relevant, other applicable studies conducted or sponsored by the HTD or by third parties, including ongoing studies, in order to include all up-to-date published and unpublished information (data, analyses and any other evidence) from studies on the medical device for which the HTD was a sponsor and corresponding information about studies by third parties, if available;

(b) bibliographic databases, including at least the National Library of Medicine's bibliographic database (MEDLINE) and the Cochrane Central Register of Controlled Trials database;

(d) HTA reports on the medical device subject to the JCA from the EEA States and from Australia, Canada, the United Kingdom and the United States of America;

(e) clinical evaluation report (CER);

(f) medical device and patient registries.

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This section shall:

(a) provide a list of the sources that were systematically searched for studies that are relevant for the JCA according to the assessment scope and indicate the date of each search, with a cut-off date for the searches of a maximum of 3 months before the submission of the dossier;

(b) report whether and when new data with relevance for the assessment scope might become available.

All search strategies shall be fully documented in Appendix D.2.

4.2.2.Selection of relevant studies This section shall document the approach for the selection of relevant studies from the results of the information retrieval according to inclusion and exclusion criteria defined in Section 4.1. That specification shall be provided for each PICO, as appropriate. The HTD shall consult the selection process suggested in the methodological guidance adopted by the Coordination Group pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282.

4.3. Methods for data analysis and synthesis This section shall describe the methods used for data analysis and synthesis following international standards of evidence-based medicine. The HTD shall consult, if available, the methodological guidance adopted by the Coordination Group pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282 and describe and justify any deviations from that guidance.

The underlying documentation for any analysis, i.e. study protocols and statistical analysis plans (including for evidence syntheses) and details on all software used, as well as the respective program code and relevant output shall be provided in the relevant parts of Appendix D.

This section shall cover the following methodological aspects in the following respective sub-sections, where relevant:

4.3.1.Description of the design and methodology of the included original clinical studies

4.3.2.Direct comparisons by pairwise meta-analyses The protocol for evidence syntheses, including the relevant statistical analysis plan, shall be provided in Appendix D.5.

4.3.3.Indirect comparisons The protocol for evidence syntheses, including the relevant statistical analysis plan, shall be provided in Appendix D.5.

4.3.4.Sensitivity analyses This section shall describe and justify the methods of all performed sensitivity analyses. It shall describe the purpose or which methodological parameter the sensitivity analysis addresses, as well as underlying assumptions.

4.3.5.Subgroup analyses and other effect modifiers

4.3.6.Specification of further methods as required This section shall describe any other methods used in deriving results used in the dossier.

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5. Results (point l of Annex II.1 to Regulation (EU) 2021/2282) The results presented in the dossier shall follow international standards of evidence-based medicine. The HTD shall consult, if available, the methodological guidance adopted by the Coordination Group pursuant to Article 3(7), point

(d), of Regulation (EU) 2021/2282 and describe and justify any deviations from that guidance.

The presentation of results shall use text, figures and tables as appropriate.

5.1. Results from the information retrieval process Results from the different steps of the information retrieval process shall be presented transparently. For each study,

the following information shall be indicated: the study reference ID, the study status, the study duration with data cut-off if applicable, and study arms. For each of the information retrieval steps, the studies not considered in the dossier shall be identified and listed. For each of them, the reason for exclusion shall be specified.

The presentation of the results shall include in the following respective sub-sections:

5.1.1.List of studies conducted or sponsored by the HTD or by third parties This section shall report information on all the studies, including ongoing studies, conducted or sponsored by the HTD and third parties, referred to in point d of Annex II.1 to Regulation (EU) 2021/2282, including all studies providing clinical safety and clinical performance data from the CER. The listing shall be restricted to studies involving patients in the medical indication for which the dossier is prepared. The section shall also report whether and when new data with relevance for the assessment scope might become available during or after the assessment period.

5.1.2.Studies identified in searches of bibliographic databases This section shall present results from searches for studies on the medical device and its comparator(s) where relevant (e.g. for indirect meta-analyses) in bibliographic databases.

5.1.3.Studies in study registries and study results registries (clinical trial databases) In accordance with point f of Annex II.1 to Regulation (EU) 2021/2282, this section shall present results from searches for studies for the medical devices and its comparator(s) where relevant in study registries/study results registries.

5.1.4.HTA reports In accordance with point e of Annex II.1 to Regulation (EU) 2021/2282, this section shall list HTA reports available on the medical device subject to the JCA from the EEA States and from Australia, Canada, the United Kingdom and the United States of America. The HTA reports shall be provided in Appendix D.6. Any additional relevant evidence identified in those HTA reports which were not identified in other sources shall be listed.

5.1.5.Studies from the CER This section shall list all clinical performance and safety studies and where relevant, other applicable studies that were included in the CER. If the main studies do not address any of the PICO(s), they shall be presented in Appendix C and be provided in Appendix D.10.

5.1.6.Studies from medical device and patient registries This section shall present results from searches for studies for the medical device and its comparator(s), where relevant, in medical device and patient registries.

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5.1.7.List of included studies overall and by PICO This section shall define the list of studies included in the dossier informing each PICO. If no evidence is available for a specific PICO question in the assessment scope, this shall be clearly reported in the dossier (‘No evidence provided by the HTD’) and duly justified.

5.2. Characteristics of included studies In accordance with point m of Annex II.1 to Regulation (EU) 2021/2282, this section shall provide an overview in tabular format of the study design and the study population for all studies included in the dossier to address any of the PICO(s). Information shall specifically be provided on:

(a) the study type and design;

(b) the study date and duration;

(d) characteristics of the intervention and comparator(s);

(e) study outcomes;

(f) if applicable, data cut-off;

(g) sample size;

(h) analysis methods.

The study interventions shall be characterised and information on the course of the study (i.e., planned and actual follow-up times per outcome) shall be provided.

The studies included in the dossier shall be described briefly. A detailed description of the study methodology shall be

provided in Appendix A.

5.3. Data analysis In accordance with Articles 9(2) and (3) of Regulation (EU) 2021/2282, this section shall present the data analysed to address each research question of the assessment scope. The data shall be presented by PICO. The presentation shall follow international standards of evidence-based medicine. The HTD shall consult, if available, the methodological guidance adopted by the Coordination Group under Article 3(7), point (d), of Regulation (EU) 2021/2282 and describe and justify any deviations from that guidance.

This section shall also provide all information that is required to assess the degree of certainty with regard to the PICO(s), taking into account the strengths and limitations of the available evidence, including, but not limited to, the risk of biases.

Details shall be provided in the relevant Appendixes.

6. List of references Appendixes Appendix A. Tabular listing and information on methods of all studies included in the JCA The appendix shall include a listing of all studies included in the dossier informing each of the PICO(s) in the assessment scope. In addition, information on study methods and a patient flow chart shall be provided for each of the listed studies.

Appendix B. Information to assess the degree of certainty with regard to the PICO(s) (including, but not limited to, the risk of biases) Appendix C. Results of the main study/studies from the clinical development programme of the medical device (if not included in the presentation by PICO question(s)) Appendix D. Underlying documentation

ELI: http://data.europa.eu/eli/reg_impl/2025/2086/oj 25/41EN OJ L, 20.10.2025 D.1. Full texts of references D.2. Documentation of information retrieval D.2.1. Documentation of search strategies for each information source D.2.2. Results of the information retrieval in standard format D.3. Programming code for programs used for analyses This appendix shall provide program code and relevant output if the analyses and corresponding calculations cannot be described by a specific standard method.

D.4. Study reports for original clinical studies This appendix shall provide clinical study reports, clinical study protocols and statistical analysis plans, referred to in point d of Annex II.1 to Regulation (EU) 2021/2282.

D.5. Study reports for evidence synthesis studies This appendix shall provide all up-to-date published and unpublished information and data-analyses, including study protocols and statistical analysis plans, referred to in point d of Annex II.1 to Regulation

(EU) 2021/2282 which are required for evidence synthesis studies. For each study, the clinical study report shall be provided only once.

D.6. HTA reports of the medical device subject to the JCA (where appropriate) D.7. Information on data from registries and studies based on registries This appendix shall include data and studies with the medical device from patient registries, if available.

D.8. Information on JSCs (where appropriate) D.9. Clinical evaluation assessment report (CEAR) D.10. Clinical evaluation report (CER) and its updates (where available) referred to in Article 61(12) of Regulation

(EU) 2017/745 and Part A of Annex XIV to Regulation (EU) 2017/745 D.11. Clinical evaluation plan (CEP) referred to in Part A of Annex XIV to Regulation (EU) 2017/745 D.12. PMCF plan and PMCF evaluation report (where available) referred to in Part B of Annex XIV to Regulation

(EU) 2017/745 or a justification why a PMCF is not applicable D.13. Opinion of the expert panels provided in the framework of the clinical evaluation consultation procedure 26/41 ELI: http://data.europa.eu/eli/reg_impl/2025/2086/ojEN OJ L, 20.10.2025 ANNEX II TEMPLATE FOR THE DOSSIER FOR THE JOINT CLINICAL ASSESSMENT OF AN IN VITRO DIAGNOSTIC MEDICAL DEVICE The provision of information, data, analysis and other evidence in the dossier shall follow international standards of evidence-based medicine. The health technology developer shall consult, if available, the methodological guidance adopted by the Member State Coordination Group on Health Technology Assessment (‘the Coordination Group’) under Article 3(7), point (d), of Regulation (EU) 2021/2282 where applicable and describe and justify any deviations from that guidance. The information requested in the dossier template shall be provided in a clear format, preferably in tabular format when possible.

Revision history Unnecessary lines shall be deleted. If needed, lines may be added.

Commission’s check Version Document Legal reference Submission date date V0.1 Initial dossier Article 10(2) of Regulation

ELI: http://data.europa.eu/eli/reg_impl/2025/2086/oj 27/41EN OJ L, 20.10.2025 Commission’s check Version Document Legal reference Submission date date V1.0.3 (Updated dossier following Article 19(5) of the initiation of an update Implementing Regulation of a JCA – update of the (EU) 2025/2086 assessment scope not needed) V1.0.4 (Updated dossier following Article 19(6) of the initiation of an update Implementing Regulation of a JCA – update of the (EU) 2025/2086 assessment scope needed) V1.0.5 (Updated dossier following Article 11(5) of Regulation N/A the initiation of an update (EU) 2021/2282 of a JCA with the HTD’s indications and justification of confidential information) V2.0 (Dossier for publication Article 21 of Implementing N/A following the finalisation Regulation (EU) 2025/2086 of an update of a JCA (without confidential information)) List of abbreviations The following list presents suggestions for abbreviations. It may be adapted to the dossier. Supplementary lines may be added, if needed.

Abbreviation Meaning EEA European Economic Area HTA Health Technology Assessment HTD Health Technology Developer IVD In vitroDiagnostic Medical Device JCA Joint Clinical Assessment JSC Joint Scientific Consultation PCR Polymerase Chain Reaction PER Performance evaluation report referred to in Article 56(6) of Regulation (EU) 2017/746 and

Section 1.3 of Annex XIII to Regulation (EU) 2017/746

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1. Overview

1.1. Information about the in vitrodiagnostic medical device under assessment (‘the IVD’) and the HTD

This section shall provide:

(a) the trade name of the IVD;

(b) the corporate name and permanent address of the HTD submitting the dossier for the JCA. In case the manufacturer to which the certificate of conformity for the IVD was issued is different from the HTD submitting the dossier, the corporate name and address of both the manufacturer and the HTD shall be specified.

1.2. Executive summary This section shall provide a concise executive summary of the dossier focusing on the assessment scope as set out pursuant to Article 8(6) of Regulation (EU) 2021/2282 and shared with the HTD in the Commission’s first request referred to in Article 10(1) of Regulation (EU) 2021/2282 (‘the assessment scope’). The executive summary shall

include:

(a) a summary of the data analysed with regard to the assessment scope. The data shall be provided for each PICO separately;

(b) the degree of certainty with regard to the PICO(s).

2. Background

2.1. Characterisation of the target patient population This section shall name and describe the target patient population(s) for the indication(s) under assessment, in line with the intended purpose of the IVD as described in the PER.

References for the statements shall be provided.

2.2. Characterisation of the IVD This section shall describe the characteristics of the IVD including the following information, where available in the PER, the clinical performance study plan (CPSP) or clinical performance study report:

(a) model(s) of the IVD including description of the different references / reference number(s) / software version;

(b) European Nomenclature on Medical Devices (EMDN)(1)description (most granular level, as relevant);

(d) specification of the analyte or marker to be determined by the IVD (e.g. SARS- CoV-2 spike protein, Kel1 (K));

(e) principle of the assay method or principles of operation of the instrument (e.g. real-time PCR, qualitative PCR, digital PCR, sandwich immunoassay, competitive immunoassay, immunoturbidimetric assay etc.);

(1) European Medical Device Nomenclature (EMDN) - EUDAMED.

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(f) whether it is automated or not;

(g) whether it is qualitative, semi-quantitative or quantitative;

(h) type of specimen(s) required (e.g. whole blood, serum, saliva etc.);

(i) intended user (e.g. self-testing, near patient and laboratory professional use, healthcare professionals);

(j) instructions for use, necessary training and experience of the user, appropriate calibration procedures and means of control, indication of any other devices, medical devices, medicinal product or other articles to be included or excluded.

References for the statements shall be provided.

3. Description of methods used in the development of the content of the dossier In accordance with Articles 9(2) and (3) of Regulation (EU) 2021/2282, this section shall describe the methods used in the development of the content of the dossier ensuring that the submitted evidence is complete and that the available data is appropriately analysed to answer the research questions of the assessment scope. The HTD shall consult, if available, the methodological guidance adopted by the Coordination Group pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282.

3.1. Criteria for selecting studies for JCA This section shall specify the inclusion and exclusion criteria for studies to be considered for this JCA based on the assessment scope. The specification for inclusion and exclusion criteria shall be provided for each PICO, as appropriate.

3.2. Selection of relevant studies The HTD shall use the literature search report included in the PER with the objective of identifying the evidence to be used for the preparation of the JCA dossier.

The HTD shall document the approach for the selection of relevant studies to address the assessment scope according to inclusion and exclusion criteria defined in Section 3.1.

To develop its selection process, the HTD shall consult, if available, the methodological guidance adopted by the Coordination Group pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282.

4. Results

4.1. Results from the selection process In accordance with Articles 9(2) and (3) of Regulation (EU) 2021/2282, this section shall transparently present results from the selection process. All available studies shall be clearly identified using e.g. the study reference ID, the study status, the study duration, and study arms. Studies not considered in the dossier shall be listed with, for each of them, the reason for exclusion.

The presentation of the results shall provide the list of studies included in the dossier, informing each PICO. If no evidence is available from the PER for a specific PICO question of the assessment scope, this shall be clearly reported in the dossier (“No evidence provided by the HTD”) and justified.

4.2. Characteristics of included studies In accordance with Articles 9(2) and (3) of Regulation (EU) 2021/2282, this section shall provide an overview in tabular format of all studies included in the dossier to address any of the PICO(s). Depending on the information available in the PER and CPSP, information shall be provided on:

(a) the study type and design;

(b) the study date and duration;

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(d) characteristics of the intervention, and comparator(s);

(e) study outcomes;

(f) if applicable, data cut-off;

(g) sample size;

(h) analysis methods.

The studies included in the dossier shall be described briefly depending on the information available in the PER and CPSP. A detailed description of the study methodology shall be provided in Appendix A.

4.3. Data analysis In accordance with Articles 9(2) and (3) of Regulation (EU) 2021/2282, this section shall present the data analysed to address the research questions of the assessment scope. The presentation shall follow international standards of evidence-based medicine. The HTD shall consult, if available, the methodological guidance adopted by the Coordination Group under Article 3(7), point (d), of Regulation (EU) 2021/2282 and describe and justify any deviations from that guidance.

This section shall also provide all information that is needed to assess the degree of certainty with regard to the PICO(s), as available from the PER or CPSP.

5. List of references Appendixes Appendix A. Tabular listing and information on methods of all studies included in the JCA The appendix shall include a listing of all studies included in the dossier to address the research question.

Appendix B. Information to assess the degree of certainty with regard to PICO(s) Appendix C. Underlying documentation C.1. Results of the selection process C.2. Performance evaluation report (PER), including the scientific validity report, the analytical performance report and the clinical performance report, together with an assessment of those reports, as referred to in

Section 1.3.2 of Annex XIII to Regulation (EU) 2017/746 C.3. Clinical performance study plan(s) (CPSP) and clinical performance study report(s) referred to in Sections

2.3.2 and 2.3.3 of Annex XIII to Regulation (EU) 2017/746 C.4. Views of the expert panel provided in the framework of the performance evaluation consultation procedure C.5. Report of the European Union reference laboratory

ELI: http://data.europa.eu/eli/reg_impl/2025/2086/oj 31/41EN OJ L, 20.10.2025 ANNEX III TEMPLATE FOR THE JOINT CLINICAL ASSESSMENT REPORT OF A MEDICAL DEVICE The provision of information, data, analysis and other evidence in the report shall follow international standards of evidence-based medicine. The information shall be provided in a clear format, preferably in tabular format when possible.

List of abbreviations The following list presents suggestions for abbreviations. It may be adapted to the report. Supplementary lines may be added, if needed.

Abbreviation Meaning CER Clinical evaluation report referred to in Article 61(12) and Section 4 of Annex XIV to Regulation (EU) 2017/745 CIP Clinical investigation plan referred to in Section 3, Chapter II, of Annex XV to Regulation

(EU) 2017/745 CIR Clinical investigation report referred to in Section 7, Chapter III of Annex XV to Regulation

PICO A set of parameters for the joint clinical assessment in terms of: Patient Population – Intervention(s) – Comparator(s) – Health Outcomes RCT Randomised Controlled Trial Table of Contents List of tables

1. General information on the JCA

This section shall provide:

(a) information on the assessor and co-assessor;

(b) an overview of the procedural steps and their dates;

(c) information on the involvement of patients, clinical experts and other relevant experts, as well as on the input received from patient organisations, healthcare professional organisations and clinical and learned societies.

The input from experts and stakeholders shall be provided in Appendix A;

(d) information on previous JCA under of Regulation (EU) 2021/2282 (same indication or new indication) where relevant;

(e) information on previous JSC under Regulation (EU) 2021/2282 where relevant.

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2. Background

2.1. Overview of the medical condition

This section shall provide:

(a) a summary of the medical condition, including the symptoms and the burden and natural progression of the medical condition, its prevalence or incidence in the EEA States, as available;

(b) a brief description of the target patient population and its characteristics reflected in the assessment scope as set out pursuant to Article 8(6) of Regulation (EU) 2021/2282;

(c) a brief description of the care pathway for the medical condition and whether it varies substantially between the EEA States, as well as, if relevant, for different stages and/or subtypes or sub-populations of the medical condition.

2.2. Characterisation of the medical device

2.2.1.Characteristics of the medical device This section shall describe characteristics of the medical device under assessment (‘the medical device’) and report the

following information:

(a) manufacturer (as mentioned on the certificate of conformity) and HTD submitting the JCA dossier if different from the manufacturer;

(b) medical device trade name;

(d) Basic UDI-DI(s) referred to in the current certificate;

(e) risk class of the medical device;

(f) European Nomenclature on Medical Devices (EMDN)(1)description (most granular level, as relevant);

(g) intended purpose;

(h) brief description of the medical device including its constituents;

(i) mode(s) of action;

(j) frequency and duration of use, if applicable;

(k) claimed medical device lifetime.

(l) when previous versions of the medical device are available, description of the main changes made to these different versions;

(m) if applicable, specific description for the connected technology;

(n) for medical devices with an embedded decision-making system based on machine learning and artificial intelligence processes, description of the functions built-in or evolving using these technologies.

2.2.2.Summary of main requirements for use This section shall include a description of the procedures and services, as well as main organisational aspects associated with the use of the medical device.

2.2.3.Regulatory status of the medical device This section shall describe the regulatory information on the medical device. It shall also provide details of ongoing or planned early access/compassionate use programs in the EEA States.

(1) European Medical Device Nomenclature (EMDN) - EUDAMED.

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3. Assessment scope This section shall reproduce the assessment scope as set out pursuant to Article 8(6) of Regulation (EU) 2021/2282.

4. Results The results presented in this section shall follow international standards of evidence-based medicine.

4.1. Information retrieval

This section shall include:

(a) a description of the information retrieval performed by the HTD;

(b) an assessment of the appropriateness of the sources and the search strategies of the HTD.

It shall provide the date of the list of the studies, conducted or sponsored by the HTD or by third parties, referred to in point d of Annex II.1 to Regulation (EU) 2021/2282, as well as the date of the last searches for the medical device and the comparator(s) in bibliographic databases and in study registries and study results registries (clinical trial databases).

Detailed information shall be provided in Appendix B.

4.1.1.Resulting list of included studies overall and by PICO

This section shall provide in tabular format:

(a) an overview of all included studies and the associated references for these studies overall and by PICO;

(b) the list of studies included by the HTD which were excluded within the assessment, with a justification for their exclusion.

4.2. Characteristics of included studies

4.2.1.Included studies

This section shall provide for the studies included in the assessment:

(a) information on the study design (e.g., on randomisation, blinding, or parallel observation studies, and the key inclusion and exclusion criteria);

(b) information on enrolled study populations (e.g., diagnosis, general severity of medical condition, and line of therapy);

(d) information on the course of the study (e.g., planned and actual follow-up times per outcome);

(e) information on the study duration.

4.2.2.Degree of certainty with regard to the PICO(s) This section shall describe the assessment of degree of certainty with regard to the PICO(s).

4.3. Study results on relative effectiveness and relative safety The results on relative effectiveness and relative safety shall be presented according to the assessment scope as set out pursuant to Article 8(6) of Regulation (EU) 2021/2282, per PICO.

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4.3.1. Results for patient population <Z-1> This section shall discuss to which extent the included patient populations and/or comparator(s) per study cover the relevant patient population/comparator(s) according to the assessment scope as set out pursuant to Article 8(6) of Regulation (EU) 2021/2282.

A separate section shall be provided for each patient population specified in the PICO(s). Within this section, the results for all PICO(s) addressing this patient population shall be presented in the following sub-sections.

4.3.1.1. Patient characteristics This section shall present patient characteristics from all studies covering the relevant patient population included in any of PICO(s) addressing this patient population.

4.3.1.2. Evidence synthesis methods This section shall briefly describe, when applicable, the evidence synthesis methods used by the HTD, including the associated strengths and limitations, and any factors arising from these methods and their application which may affect the certainty of the evidence.

4.3.1.3. Health outcome results for PICO <1> and uncertainties in the results Within the given patient population <Z-1>, results on health outcomes describing relative effectiveness and relative safety shall be described by PICO.

The sub-section shall start by describing and justifying the choice of evidence (type of comparison) submitted to address the given PICO <1>.

The sub-section shall present an overview of the available outcomes requested in the assessment scope per study.

Results on relative effectiveness and relative safety (i.e., the relative effects of the medical device versus the comparator) shall include the results from all individual studies, as well as any quantitative syntheses of results, e.g., from meta-analyses.

The results of the analyses of each of the presented outcomes shall be described briefly.

The description shall address any issues affecting the degree of uncertainty of the relative effects.

For each additional PICO question related to the given patient population <Z-1>, a new sub-section shall be created to present the results in terms of health outcomes for this PICO question.

4.3.2. Results of the main study from the clinical development programme of the medical device (if not addressed by any of PICO(s))

4.3.2.1. Characteristics of the study

4.3.2.2. Patient characteristics

4.3.2.3. Health outcome results of the study and uncertainties in the results

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5. References Appendixes Appendix A. Input from experts and stakeholders Appendix B. Assessment of information retrieval Appendix C. Additional study information and data, including uncertainties in the results 36/41 ELI: http://data.europa.eu/eli/reg_impl/2025/2086/ojEN OJ L, 20.10.2025 ANNEX IV TEMPLATE FOR THE JOINT CLINICAL ASSESSMENT REPORT OF AN IN VITRO DIAGNOSTIC MEDICAL DEVICE The provision of information, data, analysis and other evidence in the report shall follow international standards of evidence-based medicine. The information shall be provided in a clear format, preferably in tabular format when possible.

List of abbreviations The following list presents suggestions for abbreviations. It may be adapted to the report. Supplementary lines may be added, if needed.

Abbreviation Meaning CPR Clinical performance report referred to in Section 1.3.2 of Annex XIII to Regulation

(EU) 2017/746 EEA European Economic Area HTA Health Technology Assessment HTD Health Technology Developer IVD In vitroDiagnostic Medical Device JCA Joint Clinical Assessment JSC Joint Scientific Consultation PER Performance evaluation report referred to in Article 56(6) of Regulation (EU) 2017/746 and

Section 1.3 of Annex XIII to Regulation (EU) 2017/746 PMCF Post-Market Clinical Follow-up

1. General information on the JCA

This section shall provide:

(a) information on the assessor and co-assessor;

(b) an overview of the procedural steps and their dates;

(d) information on previous JCA under Regulation (EU) 2021/2282 (same indication or new indication) where relevant;

(e) information on previous JSC under Regulation (EU) 2021/2282 where relevant.

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2. Background

2.1. Characterisation of the target patient population This section shall provide a brief description of the target patient population(s) for the indication(s) under assessment, in line with the intended purpose of the IVD.

2.2. Characterisation of the in vitrodiagnostic medical device This section shall describe characteristics of the in vitrodiagnostic medical device under assessment (‘the IVD’) and

report the following information:

(a) manufacturer (as mentioned on the certificate of conformity) and HTD submitting the JCA dossier, if different from the manufacturer;

(b) the trade name of the IVD;

(d) model(s) of the IVD including description of the different references / reference number(s) / software version;

(e) European Nomenclature on Medical Devices (EMDN)(1)description (most granular level, as relevant);

(f) brief description of the IVD including its components in case the IVD is a kit;

(g) specification of the analyte or marker to be determined by the IVD (e.g. SARS- CoV-2 spike protein, Kel1 (K));

(h) principle of the assay method or principles of operation of the instrument (e.g. real-time PCR, qualitative PCR, digital PCR, sandwich immunoassay, competitive immunoassay, immunoturbidimetric assay etc.);

(i) whether it is automated or not;

(j) whether it is qualitative, semi-quantitative or quantitative;

(k) type of specimen(s) required (e.g. whole blood, serum, saliva etc.);

(l) intended user (e.g. self-testing, near patient and laboratory professional use, healthcare professionals);

(m) instructions for use, necessary training and experience of the user, appropriate calibration procedures and means of control, indication of any other devices, medical devices, medicinal product or other articles to be included or excluded.

2.3. Regulatory status of the IVD This section shall describe the regulatory information on the IVD.

3. Assessment scope This section shall reproduce the assessment scope as set out pursuant to Article 8(6) of Regulation

(EU) 2021/2282.

4. Results The results presented in this section shall follow international standards of evidence-based medicine.

(1) European Medical Device Nomenclature (EMDN) - EUDAMED.

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4.1. Information retrieval

This section shall include:

(a) a description of the information retrieval performed by the HTD;

(b) an assessment of the search strategy of the HTD.

Detailed information shall be provided in Appendix B.

4.1.1. Resulting list of included studies overall and by PICO

This section shall provide in tabular format:

(a) an overview of all included studies and the associated references for these studies overall and by PICO;

(b) the list of studies included by the HTD which were excluded within the assessment, with a justification for their exclusion.

4.2. Characteristics of included studies

4.2.1. Included studies

This section shall provide for the studies included in the assessment:

(a) information on the study design;

(b) information on enrolled study populations;

(d) information on the course of the study;

(e) information on the study duration.

4.2.2. Degree of certainty with regard to the PICO(s) This section shall describe the assessment of degree of certainty with regard to the PICO(s).

An assessment of the degree of certainty of the relative effectiveness and relative safety, considering the strengths and limitations of the available evidence.

ELI: http://data.europa.eu/eli/reg_impl/2025/2086/oj 39/41EN OJ L, 20.10.2025

4.3.1.3. Outcome results for PICO <1> and uncertainties in the results Within the given patient population <Z-1>, results on outcomes describing relative effectiveness and relative safety shall be described by PICO.

The sub-section shall start by describing and justifying the choice of evidence (type of comparison) submitted to address the given PICO <1>.

The sub-section shall present an overview of the available outcomes requested in the assessment scope per study.

Results on relative effectiveness and relative safety (i.e., the relative effects of the IVD versus the comparator) shall include the results from all individual studies and if available any quantitative syntheses of results, e.g., from meta- analyses.

The results of the analyses of each of the presented outcomes shall be described briefly.

The description shall address any issues affecting the degree of uncertainty of the relative effects.

For each additional PICO question related to the given patient population <Z-1>, a new sub-section shall be created to present the results in terms of outcomes for this PICO question.

4.3.2. Results of the main study from the PER of the IVD (if not addressed by any of PICO(s))

4.3.2.1. Characteristics of the study

4.3.2.2. Patient characteristics

4.3.2.3. Outcome results of the study and uncertainties in the results

5. References Appendixes Appendix A. Input from experts and stakeholders Appendix B. Assessment of information retrieval Appendix C. Additional study information and data, including uncertainties in the results 40/41 ELI: http://data.europa.eu/eli/reg_impl/2025/2086/ojEN OJ L, 20.10.2025 ANNEX V TEMPLATE FOR THE JOINT CLINICAL ASSESSMENT SUMMARY REPORT ON A MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE The summary report shall be concise and an independently readable overview of the assessment.

The summary report shall include, at least the following information:

(a) a description of the intervention, medical condition and/or target population;

(b) the assessment scope provided for in Article 8(6) of Regulation (EU) 2021/2282;

(d) summary tables including uncertainties of the evidence for each set of parameters for the joint clinical assessment in terms of patient population, intervention, comparators and outcomes, with short description of the results.

ELI: http://data.europa.eu/eli/reg_impl/2025/2086/oj 41/41

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