Proposal For EMA To Provide Medtech Expert Panel Structure Gains Traction
The medtech industry has long resisted having the European Medicines Agency involved in device oversight. Now an EU-level proposal is making device makers nervous.
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The new EU regulation on increasing powers of the European Medicines Agency in future health crises applies as of 1 March; it controversially sees the agency become more involved in device oversight.
Industry opposes the proposed new role of European Medicines Agency in overseeing devices availability in a healthcare crisis. But a new Regulation may be adopted in March and its fallout looks set to herald a new era for device supply management and regulation.
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.