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.November.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. Ziel des Whitepapers ist es, Aufmerksamkeit auf das drängende Thema der Neuklassifizierung und das Erreichen der rechzeitigen Compliance gemäss der Medizinprodukteverordnung zu lenken. Es soll als Orientierungshilfe mit Vorschlägen für praktische Schritte dienen, die Hersteller von Produkten der Klasse I so bald wie möglich unternehmen sollten.