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MDCG 2022-18 – Position Paper – application of Art.97 MDR to legacy devices for which an MDD/AIMDD certificate expires before the issuance of a MDR certificate

The document aims to achieve a common understanding of and a uniform approach to the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) in situations where a device is not in conformity with the MDR because its certificate issued under Directive 93/42/EEC or Directive 90/385/EEC has expired or expires before issuance of the necessary certificate(s) in accordance with the MDR.

Read the news announcement published by EC Directorate-General for Health and Food Safety on 9 December 2022.


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (24 janvier 2023). MDCG 2022-18 – Position Paper – application of Art.97 MDR to legacy devices for which an MDD/AIMDD certificate expires before the issuance of a MDR certificate. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/o66d


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