Since this whitepaper was first published, there have been some significant changes to the EU Medical Device Regulation (EU MDR), with 2 corrigenda and a formal revision. The formal revision (April 2020) where the Date of Application (DoA) was extended by a year to 26 mai 2021 was certainly noteworthy. However for Class I medical device manufacturers, by far the most significant change was the corrigendum of 25 novembre 2019 whereby Class I manufacturers for devices that are reusable (Class Ir), sterile (Class Is), measuring (Class Im) or any combination of these, were effectively given a 4-year extension to become EU MDR compliant. Manufacturers of non-reusable, non-sterile and non-measuring devices, who cannot benefit from this extension, are under heightened time pressure to comply with the new regulation by May 2021.

This whitepaper has been updated to serve as a valuable tool for Class I medical device manufacturers to help ensure they maintain EU market access. Le but de ce livre blanc est d’élever la sensibilité à la question brûlante du traitement de la requalification et d’obtenir une conformité au RDM dans les délais, de fournir des conseils et des étapes pratiques que les fabricants de Catégorie I devraient suivre dès que possible.