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Date: 25-Jan-2024 Category: Not Applicable State: Union Government Country: Europe

Decision of the EEA Joint Committee No 144/2021 of 23 April 2021 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/143]

Issued by EEA Joint Committee · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • The EEA Joint Committee Decision No 144/2021 amends Annex II to the EEA Agreement to incorporate Commission Implementing Regulation (EU) 2017/2185. This regulation concerns the list of codes and corresponding types of devices for specifying the scope of designation as notified bodies in the field of medical devices and in vitro diagnostic medical devices.

Key Changes

  • The decision inserts point 14 after point 13 in Chapter XXX of Annex II to the EEA Agreement, referencing Commission Implementing Regulation (EU) 2017/2185.
  • Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 is incorporated into the EEA Agreement.
  • The authentic texts of Implementing Regulation (EU) 2017/2185 in Icelandic and Norwegian languages will be published in the EEA Supplement to the Official Journal of the European Union.
  • The Decision entered into force on 24 April 2021, provided all notifications under Article 103(1) of the EEA Agreement have been made.

Impact Analysis

Medical Device Manufacturers and Notified Bodies

  • Action Item: Notified Bodies should update their scope of designation to reflect the requirements of Regulation (EU) 2017/2185.

EEA Member States

  • Action Item: Ensure that national competent authorities are informed and prepared to enforce the new requirements.

European Commission

  • Action Item: Monitor the implementation of this decision by EEA member states.

Key Entities Referenced

EEA Joint Committee: The decision-making body responsible for the management of the EEA Agreement. Commission Implementing Regulation (EU) 2017/2185: Regulation on the list of codes and corresponding types of devices for specifying the scope of the designation as notified bodies in the field of medical devices and in vitro diagnostic medical devices. EEA Agreement: The Agreement on the European Economic Area, which extends the EU's internal market to Iceland, Liechtenstein and Norway. Regulation (EU) 2017/745: Regulation of the European Parliament and of the Council on medical devices. Regulation (EU) 2017/746: Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices.
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Official Journal EN of the European Union L series 2024/143 25.1.2024 DECISION OF THE EEA JOINT COMMITTEE No 144/2021 of 23 April 2021 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/143] THE EEA JOINT COMMITTEE, Having regard to the Agreement on the European Economic Area (“the EEA Agreement”), and in particular Article 98 thereof, Whereas: (1) Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council(1) is to be incorporated into the EEA Agreement. (2) Annex II to the EEA Agreement should therefore be amended accordingly, HAS ADOPTED THIS DECISION: Article 1 The following point is inserted after point 13 (Commission Implementing Decision (EU) 2019/939) of Chapter XXX of Annex II to the EEA Agreement: ‘14. 32017 R 2185: Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (OJ L 309, 24.11.2017, p. 7).’ Article 2 The text of Implementing Regulation (EU) 2017/2185 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic. Article 3 This Decision shall enter into force on 24 April 2021, provided that all the notifications under Article 103(1) of the EEA Agreement have been made*. Article 4 This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union. (1) OJ L 309, 24.11.2017, p. 7. * No constitutional requirements indicated. ELI: http://data.europa.eu/eli/dec/2024/143/oj 1/2EN OJ L, 25.1.2024 Done at Brussels, 23 April 2021. For the EEA Joint Committee The President Clara GANSLANDT 2/2 ELI: http://data.europa.eu/eli/dec/2024/143/oj

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