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

Decision of the EEA Joint Committee No 23/2024 of 2 February 2024 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/1546]

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 23/2024 amends Annex II to the EEA Agreement to incorporate Commission Delegated Regulation (EU) 2023/2197 regarding Unique Device Identifiers (UDI) for contact lenses.

Key Changes

  • The decision incorporates Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 into the EEA Agreement, specifically Annex II, Chapter XXX, point 11.
  • Regulation (EU) 2023/2197 concerns the assignment of Unique Device Identifiers (UDI) for contact lenses and amends Regulation (EU) 2017/745.
  • The text of Delegated Regulation (EU) 2023/2197 in Icelandic and Norwegian languages will be published in the EEA Supplement to the Official Journal of the European Union and shall be authentic.
  • The Decision entered into force on 3 February 2024, provided that all notifications under Article 103(1) of the EEA Agreement have been made.

Impact Analysis

Manufacturers of Contact Lenses

  • Action Item: Review internal processes to ensure compliance with UDI requirements for contact lenses and update labeling and tracking systems accordingly.

Healthcare Providers and Distributors

  • Action Item: Update inventory management systems to accommodate UDI information for contact lenses and train staff on UDI requirements.

EEA Member States

  • Action Item: Review and update national regulations to reflect the requirements of Commission Delegated Regulation (EU) 2023/2197.

Consumers

  • Action Item: No direct action required, but awareness of UDI on contact lens packaging may increase confidence in product safety.

Key Entities Referenced

EEA Joint Committee: The body responsible for adopting decisions related to the EEA Agreement. Commission Delegated Regulation (EU) 2023/2197: Regulation amending Regulation (EU) 2017/745 regarding the assignment of Unique Device Identifiers for contact lenses. Regulation (EU) 2017/745: Regulation of the European Parliament and of the Council on medical devices. EEA Agreement: 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 2024/1546 27.6.2024 DECISION OF THE EEA JOINT COMMITTEE No 23/2024 of 2 February 2024 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/1546] 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 Delegated Regulation (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses(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 11 (Regulation (EU) 2017/745 of the European Parliament and of the Council) of Chapter XXX of Annex II to the EEA Agreement: ‘— 32023 R 2197: Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023(OJ L, 2023/2197, 20.10.2023).’ Article 2 The text of Delegated Regulation (EU) 2023/2197 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, 2023/2197, 20.10.2023. (*) Constitutional requirements indicated. ELI: http://data.europa.eu/eli/dec/2024/1546/oj 1/1

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