Date: 2025-11-27Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices referred to in Article 34(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary**
This Commission Decision (EU) 2025/2371, dated 26 November 2025, confirms that certain electronic systems within the European Database on Medical Devices (Eudamed) are functional and meet the specifications of Article 34(1) of Regulation (EU) 2017/745. The Decision validates the functionality of four electronic systems related to economic operators, devices, notified bodies, and market surveillance. This decision enters into force on the day of its publication.
**Key Points / Main Content**
* **Functionality Confirmation:**
* The Decision confirms the functionality and specification compliance of four Eudamed electronic systems.
* **Covered Electronic Systems:**
* Electronic system on registration of economic operators as per Article 30 of Regulation (EU) 2017/745 and Article 27 of Regulation (EU) 2017/746.
* UDI database and the electronic system for registration of devices as per Articles 28 and 29 of Regulation (EU) 2017/745 and Articles 25 and 26 of Regulation (EU) 2017/746.
* Electronic system on notified bodies and certificates as per Article 57 of Regulation (EU) 2017/745 and Article 52 of Regulation (EU) 2017/746.
* Electronic system on market surveillance as per Article 100 of Regulation (EU) 2017/745 and Article 95 of Regulation (EU) 2017/746.
* **Entry into Force:**
* The Decision enters into force on the day of its publication in the Official Journal of the European Union.
**Impact Analysis**
**Economic Operators, Manufacturers, and Distributors**
* **Impact:** The activation of the electronic system for registration of economic operators simplifies the process of registration and information management, but also mandates their use.
* **Action Required:** Economic operators must register and maintain accurate data in the new system in accordance with the regulations.
**Notified Bodies**
* **Impact:** Activation of the electronic system for notified bodies and certificates standardises and centralises the information related to their designation, certificates issued, and monitoring activities.
* **Action Required:** Notified Bodies are required to use the electronic system for updates and maintenance of all relevant information.
**EU Member States Competent Authorities (Market Surveillance)**
* **Impact:** The operational market surveillance electronic system facilitates data exchange and coordination in post-market monitoring of medical devices, enhancing the effectiveness of regulatory actions.
* **Action Required:** Authorities are required to adapt and utilize the electronic system for reporting and coordinating surveillance activities.
Key Entities Referenced
Regulation (EU) 2017/745: Regulation of the European Parliament and of the Council on medical devices. This decision concerns electronic systems within the European Database on Medical Devices (Eudamed) as per Article 34(1) of this Regulation.
Eudamed: The European Database on Medical Devices, including electronic systems for economic operator registration, UDI database, notified bodies/certificates, and market surveillance. This decision confirms that specified systems within Eudamed are functional.
Medical Device Coordination Group ('MDCG'): Collaborated with the Commission in drawing up functional specifications of Eudamed.
Official Journal EN
of the European Union L series
2025/2371 27.11.2025
COMMISSION DECISION(EU) 2025/2371
of 26 November 2025
on the notice regarding the functionality and the fulfilment of the functional specifications of certain
electronic systems included in the European Database on Medical Devices referred to in Article 34(1)
of Regulation (EU) 2017/745 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to 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(1), and in particular Article 34(3) thereof,
Whereas:
(1) According to Article 33(1) of Regulation (EU) 2017/745 and Article 30(1) of Regulation (EU) 2017/746 of the
European Parliament and of the Council(2), the Commission is to set up, maintain and manage the European
Database on Medical Devices (Eudamed). Eudamed is to include the electronic systems listed in Article 33(2) of
Regulation (EU) 2017/745 and Article 30(2) of Regulation (EU) 2017/746.
(2) On 15 December 2022, the Commission published the latest consolidated version of the functional specifications of
Eudamed (version 7.2)(3), which it had drawn up in collaboration with the Medical Device Coordination Group
(‘MDCG’) in accordance with Article 34(1) of Regulation (EU) 2017/745.
(3) In accordance with Article 34(2) of Regulation (EU) 2017/745, the Commission requested an independent audit on
the Eudamed electronic systems for which the development has been completed. Such electronic systems are the
electronic system on registration of economic operators (‘Actors’), the UDI database and the electronic system for
registration of devices (‘UDI and devices’), the electronic system on notified bodies and certificates (‘Notified bodies
and certificates’), and the electronic system on market surveillance (‘Market surveillance’).
(4) On the basis of the independent audit report of 18 June 2025 on the ‘Actors’, ‘UDI and devices’, ‘Notified bodies and
certificates’, and ‘Market surveillance’ electronic systems, the Commission has verified that such electronic systems
are functional and meet the relevant functional specifications drawn up pursuant to Article 34(1) of Regulation
(EU) 2017/745.
(5) As set out in Article 123(3), points (d) to (ec), of Regulation (EU) 2017/745 and Article 113(3), points (f) to (fd) of
Regulation (EU) 2017/746, the transition periods for the obligations and requirements that relate to any of the
electronic systems referred to in those Regulations are to start as from the date of publication of this Decision on the
notice as referred to in Article 34(3) of Regulation (EU) 2017/745, informing that the relevant electronic systems are
functional and meet the functional specifications.
(6) In order to ensure legal certainty and a clear timeline for the mandatory use of the electronic systems declared
functional, this Decision should enter into force on the day of its publication.
(1) OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj.
(2) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic 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).
(3) https://health.ec.europa.eu/system/files/2022-12/md_eudamed_fs_v7_2_en.pdf.
ELI: http://data.europa.eu/eli/dec/2025/2371/oj 1/2EN
OJ L, 27.11.2025
HAS ADOPTED THIS DECISION:
Article 1
It is hereby confirmed that the following electronic systems included in the European Database on Medical Devices
(Eudamed) have achieved functionality and meet the functional specifications, as referred to in Article 34(2) of Regulation
(EU) 2017/745:
(a) the electronic system on registration of economic operators referred to in Article 30 of Regulation (EU) 2017/745
and Article 27 of Regulation (EU) 2017/746;
(b) the UDI database and the electronic system for registration of devices referred to in Articles 28 and 29 of Regulation
(EU) 2017/745 and Articles 25 and 26 of Regulation (EU) 2017/746;
(c) the electronic system on notified bodies and certificates referred to in Article 57 of Regulation (EU) 2017/745 and
Article 52 of Regulation (EU) 2017/746;
(d) the electronic system on market surveillance referred to in Article 100 of Regulation (EU) 2017/745 and Article 95
of Regulation (EU) 2017/746.
Article 2
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.
Done at Brussels, 26 November 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/2 ELI: http://data.europa.eu/eli/dec/2025/2371/oj