The European Commission has made it very clear that the deadline for conformity to the new EU Medical Device Regulation (MDR) is May 26, 2020. But what does this mean exactly?
According to the European Commission, the MDR transition period started the date that the regulation was published. So that means the transition period spans from May 26, 2017 to May 26, 2020. It is widely misunderstood that the transition period begins on May 26, 2020 - but it actually ends on that date. After May 26, 2020, all medical devices of all classes must meet the requirements of the EU MDR for their Quality Management System (QMS) and annual regulatory submissions.
Cause for Concern
A source of worry for the Commission is the misinformation generated by Article 120. This Article indicates that it is not necessary to renew your CE mark until its expiration date, meaning it could remain CE marked even after the deadline for conformity on May 26, 2020. The danger here is that this does NOT involve the Quality Management System (QMS) or the safety-related presentations that must be submitted annually for Class IIb and Class III medical devices. This is a very real concern of the European Commission and they are working to reverse this misunderstanding.
It's important to note that devices that are self-certificated (i.e. Class I, very low risk devices) must also comply with the new regulations by the deadline in May. However, since these low risk devices don't require any submission to a Notified Body this simply means that the device's Technical Files must be up-to-date and compliant under the new MDR by the deadline. Although this isn't exactly being regulated or "checked" on by the Commission, if a company were to get audited and they did NOT have their Technical Files up to date, they would not be looked upon kindly by the Commission or the Notified Bodies.
If you're interested in learning more, RQMIS will be hosting a live webinar on March 10th explaining the new EU MDR and its impacts on business. This event is open to anyone, all you need to do is register for the event!
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