Removing EU’s Innovative Device Blockage: Expert Panels Due By End Of July After Lengthy Delays
The speed to market for innovative products in the EU has been hampered because of the time it has taken to set up “expert panels” under the Medical Device Regulation. Will these products now make 26 May 2021 deadline?
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Until the EU’s MDR expert panels are in place, notified bodies cannot complete conformity assessment of certain high-risk devices. But progress is being made at last.
Manufacturers That Are Nearly MDR-Ready May Lose Their Advantage Unless Audits Can Take Place Virtually
Industry is urgently seeking certainty over EU virtual notified body audits, fearing that companies now at the front of the MDR line might be sent to the back and have to reapply under the existing directives.
Only just over a month ago there were fears that the implementation of the EU Medical Device Regulation was going to be hampered by a lack of expert panel applicants. Now it seems there is no shortage. The news raises lots of questions about when and how the structure will now work.