Steps are underway in Germany to ensure that the need to draft an amending text to the Medical Device Regulation features in the official mission letter from the president of the European Commission to the new intake of commissioners who will be nominated for office after the just-concluded EU parliamentary elections.
Amendment To MDR May Be First Legislative Proposal Of New European Commission
How Germany, which has the EU’s largest medtech manufacturing base, is pressing for the MDR to feature on the mission letter for the new European Commission and could influence the pace of change.
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Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.
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As deadlines approach, the regulatory landscape for medtech batteries is set to change, with an emphasis on sustainability and ethical practices.
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