EU Adopts Tougher Standards for Auditing Medical Devices


EU Adopts Tougher Standards For Auditing Medical Devices


The European Commission has adopted new rules on the role of notified bodies in reviewing medical devices and IVDs in the wake of the PIP breast implant scandal.
All 8o of the European “notified bodies”, which verify medical device CE quality marks, must be authorised by assessors drawn from the member states and commission.
Until now, most medical devices have not been subject to regulatory approval but only quality controls by notified bodies.  This has made Europe an enticing market for manufacturers who launch in the EU ahead of the US.
Following the Commissions decision, countries will be expected to audit the notified bodies to ensure they maintain the new standards and further rules will be issued stipulating the qualifications required for people they hire.  The regulatory bodies will be expected to perform random, unannounced visits and sample testing on manufacturers and check that they meet safety standards
Authorities consider these interim rules vital to providing additional patient safeguards for medical devices since full regulatory implementation may be years away.
Onorach can assist both in understanding the new standards, and with medical device clinical trials.  Please contact

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