6. — Regulation (EU) 2022/123 of the European Parliament and of the Council of 25…

6.

Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Text with EEA relevance) · European Union

Where manufacturers of medical devices referred to in paragraph 1 are established outside the Union, the information requested in accordance with this Article shall be provided by the authorised representatives, or, if appropriate, by importers or distributors.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.