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EU Notified Body Designation Process: 20-Month Wait Is Not Good News

 
• By Amanda Maxwell

The EU's Notified Bodies Operations Group's just issued a best-practice guide on the designation and notification of conformity assessment bodies under the MDR and IVDR. It makes for sobering reading.

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The latest 16-page guide from the EU Notified Bodies Operations Group – NBOG BPG 2017-1 – has come as a harsh reality check for medtech companies looking to stay ahead of new compliance deadlines. Anyone who thought that the urgent need for notified bodies to be designated against the EU's Medical Device and IVD Regulations would mean an accelerated review by the designating authorities will be disappointed.

The procedures and timelines are outlined in NBOG's Best Practice Guide (BPG) on the designation and notification of...

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