The European Commission has adopted two rules on the role of notified bodies in reviewing medical devices and IVDs. "We now have a clearer basis for unannounced audits, sample testing or joint assessments by notified bodies," said EU Commissioner for Consumer Policy Neven Mimica. Authorities consider these interim rules vital to providing additional patient safeguards for medical devices since full regulatory implementation may be years away.
EU adopts rules for auditing medical devices, IVDs
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