Two experts -- Erik Vollebregt of Axon Lawyers and Mika Reinikainen of AbNovo consultants -- believe that the European Parliament's proposal for pre-market authorization for medical devices would most likely be unwieldy if approved, but the politics of the issue are murky and the outcome of the debate unpredictable. Reinikainen believes the EU would do better to improve the current system, and Vollebregt added that the proposal is hostile to innovation by assuming that anything innovative carries more risk.

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