EMA Attracts Mostly Small Companies to MDR “Advice” Pilot

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ARTICLE SUMMARY:

SMEs account for most of the first-round submissions to a new EU Medical Device Regulation pilot offering “scientific advice” on clinical trial design to help streamline subsequent notified body reviews.

Small to medium-sized enterprises dominated the first tranche of applicants to a new European Medicines Agency pilot program providing clinical trial advice for prospective Medical Device Regulation submissions.

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