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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