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Date: 8-Feb-2024 Category: Not Applicable State: Union Government Country: Europe

Decision of the EEA Joint Committee No 211/2021 of 9 July 2021 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/284]

Issued by EEA Joint Committee · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • The Decision of the EEA Joint Committee No 211/2021 amends Annex II to the EEA Agreement to incorporate Commission Implementing Regulation (EU) 2020/1207 regarding common specifications for the reprocessing of single-use devices.

Key Changes

  • Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020, which lays down rules for the application of Regulation (EU) 2017/745 concerning the reprocessing of single-use devices, is now integrated into the EEA Agreement.
  • The amendment adds point 15 to Chapter XXX of Annex II of the EEA Agreement, referencing '32020 R 1207: Commission Implementing Regulation (EU) 2020/1207'.
  • The authentic text of Implementing Regulation (EU) 2020/1207 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 10 July 2021, contingent upon all notifications under Article 103(1) of the EEA Agreement being made.

Impact Analysis

Manufacturers of Single-Use Devices

  • Manufacturers should ensure compliance with Regulation (EU) 2017/745 and Commission Implementing Regulation (EU) 2020/1207.

Healthcare Providers

  • Action Item: Review and update reprocessing protocols to align with the requirements of Commission Implementing Regulation (EU) 2020/1207. Provide training to relevant staff.

National Competent Authorities

  • Action Item: Update market surveillance procedures to include the requirements of Commission Implementing Regulation (EU) 2020/1207. Conduct inspections of reprocessing facilities.

EEA Member States (Iceland and Norway)

  • Action Item: Review national legislation and regulations to ensure full implementation of Commission Implementing Regulation (EU) 2020/1207. Publish the authentic language versions.

Key Entities Referenced

EEA Joint Committee: The decision-making body responsible for amending the EEA Agreement. Commission Implementing Regulation (EU) 2020/1207: Lays down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices. Regulation (EU) 2017/745: Regulation of the European Parliament and of the Council on medical devices. EEA Agreement: Agreement on the European Economic Area.
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Official Journal EN of the European Union L series 2024/284 8.2.2024 DECISION OF THE EEA JOINT COMMITTEE No 211/2021 of 9 July 2021 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/284] 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) 2020/1207 of 19 August 2020laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices(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 14 (Commission Implementing Regulation (EU) 2017/2185) of Chapter XXX of Annex II to the EEA Agreement: ‘15. 32020 R 1207: Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices (OJ L 273, 20.8.2020, p. 3).’ Article 2 The text of Implementing Regulation (EU) 2020/1207 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 10 July 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. Done at Brussels, 9 July 2021. For the EEA Joint Committee The President Rolf Einar FIFE (1) OJ L 273, 20.8.2020, p. 3. * No constitutional requirements indicated. ELI: http://data.europa.eu/eli/dec/2024/284/oj 1/1

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