Rocky Road So Far For Opinions Published By Device Expert Panels
The EU expert panel review is a critical step in the outcome of notified body assessment for certain high-risk devices. But slow progress has been made so far, highlighting many challenges.
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Expert panel review of clinical files for high-risk devices is happening for the first time under the new EU medtech regulations. The process has begun but expert panel opinions may be rarer than many had originally expected.
Originally intended to increase medical device safety, the EU’s medtech regulation is so hampered in its implementation that it is now arguably a bigger potential threat to patients than any of the scandals leading to its more stringent requirements.