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Amendment To MDR May Be First Legislative Proposal Of New European Commission

 
• By Amanda Maxwell

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.

leadership
German forces are leading the EU in attempting to drive through Liese-style changes to medtech regulations • Source: Alamy

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.

Two German federal states, Bavaria and Bade-Württemberg, have sent a letter to the current president of the European Commission, Ursula...

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Court Orders US FDA To Return Trial Diversity Action Plan Guidance To Website

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

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• By Brian Bossetta

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