(b)

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

instances of non-compliance with the obligations set out in Articles 10 and 26 by marketing authorisation holders, manufacturers of medical devices, authorised representatives, importers, distributors and notified bodies;

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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.