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 May 26, 2021 was certainly noteworthy. However for Class I medical device manufacturers, by far the most significant change was the corrigendum of November 25, 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. The aim of the whitepaper is to raise awareness of the pressing issue of dealing with reclassification and achieving timely compliance under the MDR, providing guidance and practical steps that Class I manufacturers should take as soon as possible.