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

2.

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

Manufacturers of medical devices, or their authorised representatives, as applicable, notified bodies and, if appropriate, importers or distributors shall justify any failure to provide requested information and any delays in providing requested information by the deadline set by the Agency.

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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.