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Why Many MDD Certificates Will Be Invalid Before Their MDR Replacements Can Be Issued

 
• By Amanda Maxwell

The initial virtual audit ban is just one obstacle to timely EU MDR compliance. Another is that many companies have seriously underestimated how much time they need, even with the grace period.

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In the EU, a significant number of medtech manufacturers will find that their conformity assessment certificate for CE marking under the Medical Devices Directive (MDD) becomes invalid before their notified body is able to issue a certificate under the Medical Device Regulation (MDR).

That was the view of Klaus-Dieter Ziel, managing director of German notified body MEDCERT when speaking at the 1 October “taster sessions” for the RMD’s January 2021 conference on the new EU medical device regulations

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