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Unofficial consolidated textConsolidated 2025-01-10English

Article 91

Reproduced from official EUR-Lex 10/1/2025.

Official catalogue · non-binding

Related guidance (3)

Current English catalogue entries that refer to Article 91. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2022-12Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)July 2022
MDCG 2022-8Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/ECMay 2022
MDCG 2019-7 - rev.1Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)December 2023

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