1.

In order to prepare for the fulfilment of the tasks referred to in Articles 22, 23 and 24, the Agency shall: specify the procedures and criteria for establishing and reviewing the public health emergency critical devices list.; develop streamlined IT monitoring and reporting systems, in coordination with the relevant national competent authorities, that facilitate interoperability with existing IT tools and Eudamed, once it is fully functional, and provide the adequate support to national competent authorities for monitoring and reporting; establish the working party referred to in Article 21(5) and ensure that each Member State is represented on that working party; specify the methods for the provision of recommendations referred to in Article 24(3) and (4) and for the coordination of measures referred to in Article 24. For the purposes of the first subparagraph, point (a), the MDCG, representatives of manufacturers, other relevant actors in the supply chain for the medical device sector and representatives of healthcare professionals, of patients and consumers may be consulted as necessary.

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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.