The European Parliament has voted to tighten oversight of medical devices, but declined to establish a review process similar to the FDA's premarket approval program. The Parliament, however, backed adoption of unannounced inspections and stricter certification standards for "notified bodies" that determine product safety. The Parliament and EU governments have yet to finalize the rules.
Proposal to toughen medtech regulations in Europe advances
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Coats and Bennett PLLC
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BASF, The Chemical Co.
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Meridian Health Plan