On May 26th 2021, the European Union’s Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) will be replaced and fully covered by the Medical Device Regulation (MDR). Since the original medical device directive’s...
The European Commission (EC) announced this week that it will now be accepting remote audits during the pandemic for some European medical device and in vitro companies. The cleared pathway comes in time for upcoming deadlines in May 2021 and 2022 for the EU’s MDR...
The FDA is implementing a body of accredited testing facilities to streamline the medical device testing process internationally. The agency has released final guidelines for the program today (9/25) outlining the steps medical device companies must take in order to...
The European Commission’s Medical Device Coordination Group (MDCG) posted five new guidances on Friday (4/24) for medical devices in light of COVID-19. These guidances are used when demonstrating equivalence to existing devices,...
In a unanimous decision on Wednesday (4/22), the European Union has decided to push back the amendment to the EU MDR by one year amidst the COVID-19 pandemic. This extra time will allow more time to ensure the functionality and design of the new system, while also...
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