Commission Needs To Prioritize Devices Agency Above All Else

Biomedical Alliance wants the EU to expand medtech regulatory oversight, especially in the areas of clinical and scientific coordination

Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.

The European Medicines Agency's building in Amsterdam — Will the European Medicines Agency become much more pivotal for medtech? • Source: Alamy

Key Takeaways

Biomedical Alliance calls out current gaps and lack of transparency in the EU when it comes to clinical and scientific requirements and expertise
Clinical and scientific expertise could be concentrated at the EMA, while having the European Commission essentially keep its current roles
Better scientific and clinical coordination could empower notified bodies to make more consistent decisions

Achieving coordination within a single European agency is an absolute priority without which

That is what Tom Melvin, who was recently appointment chairperson of the regulatory affairs committee at Biomedical Alliance, told Medtech Insight following publication of its Review of the

Commission Needs To Prioritize Devices Agency Above All Else

Biomedical Alliance wants the EU to expand medtech regulatory oversight, especially in the areas of clinical and scientific coordination

Key Takeaways

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