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Date: 27-Jun-2024 Category: Not Applicable State: Union Government Country: Europe

Decision of the EEA Joint Committee No 14/2024 of 2 February 2024 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/1554]

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 14/2024 incorporates Commission Regulation (EU) 2023/2482 into the EEA Agreement by amending Annex II. This regulation addresses the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices.

Key Changes

  • The decision adds a new indent to point 12zc of Chapter XV of Annex II to the EEA Agreement, specifically referencing Commission Regulation (EU) 2023/2482 of 13 November 2023 (OJ L, 2023/2482, 14.11.2023).
  • Regulation (EU) 2023/2482 amends Regulation (EC) No 1907/2006 concerning DEHP in medical devices.
  • The decision entered into force on 3 February 2024, following notifications under Article 103(1) of the EEA Agreement.

Impact Analysis

Medical Device Manufacturers

  • Action Item: Update documentation and labeling to reflect the changes mandated by the regulation.

Healthcare Providers

  • Action Item: Evaluate the impact of the regulation on existing inventory and procurement practices.

EEA Member States

  • Action Item: Communicate the changes to relevant stakeholders within their jurisdiction.

European Commission

  • Action Item: Monitor compliance with Regulation (EU) 2023/2482 across the EEA.

Key Entities Referenced

EEA Joint Committee: The decision-making body responsible for amending the EEA Agreement. Commission Regulation (EU) 2023/2482: Regulation amending Regulation (EC) No 1907/2006 regarding DEHP in medical devices. Regulation (EC) No 1907/2006: The original regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). EEA Agreement: The Agreement on the European Economic Area.
Official Source Record View Original Source →
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Official Journal EN of the European Union L series 2024/1554 27.6.2024 DECISION OF THE EEA JOINT COMMITTEE No 14/2024 of 2 February 2024 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/1554] 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 Regulation (EU) 2023/2482 of 13 November 2023amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical 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 indent is added in point 12zc (Regulation (EC) No 1907/2006 of the European Parliament and of the Council) of Chapter XV of Annex II to the EEA Agreement: ‘— 32023 R 2482: Commission Regulation (EU) 2023/2482 of 13 November 2023(OJ L, 2023/2482, 14.11.2023).’ Article 2 The text of Regulation (EU) 2023/2482 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 3 February 2024, 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, 2 February 2024. For the EEA Joint Committee The President Nicolas VON LINGEN (1) OJ L, 2023/2482, 14.11.2023. (*) No constitutional requirements indicated. ELI: http://data.europa.eu/eli/dec/2024/1554/oj 1/1

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