EU Commission Takes Steps to Delay MDR Implementation by One Year
Bowing to pressure from industry trade associations, Notified Bodies and Member States, the EU Commission announced today that it was requesting the authority from the EU Parliament and EU Council to delay the required May 26 implementation date of the MDR for one year.  The Commission realized that Covid-19 had created insurmountable challenges for medical device companies, Notified Bodies, healthcare providers and others.  The EU Commission is expected to include legal language in the request to ensure that CE Marks obtained under the MDD remain valid for the extended transition period to the MDR.

While there are a lot of other issues and questions to still work out, the EU Commission has realized that maintaining the May 26 MDR deadline was impractical and potentially dangerous for those who may be in dire need of a wide range of medical supplies.  See link.

As you may have heard, the EU Commission has also waived the need for a CE Mark for some very specific products that may come to the market from new unregistered sources, e.g. face masks, protective eyewear, some gowns, etc.  For more information please see the link.

MDMA will keep you informed as we get more information and updates.