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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

Following the reporting on the results of the monitoring referred to in Article 23 and any recommendations on preventive or mitigating measures provided in accordance with Article 24, manufacturers of medical devices, or their authorised representatives, and, if appropriate, importers and distributors referred to in paragraph 1, shall: provide any comments they have to the Agency; take into account any recommendations referred to in Article 24(3) and (4) and any guidelines referred to in Article 28, point (b); comply with any measures taken at Union or Member State level pursuant to Article 27 or 28; inform the MDSSG of any measures taken and report on the results of those measures, including providing information on the resolution of the actual or potential shortage of medical devices.

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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.