ISO 14971 versus the EU Commission

The debate over ISO 14971 continues between industry and the European Commission. The joint ISO & IEC working group responsible for ISO 14971 met and determined that ISO 14971 still represents the state of the art for medical device risk management and that no changes were needed, despite the position of the EC that ISO 14971 does not meet the essential requirements of the directives. Several notified bodies and COCIR/Eucomed have produced guidance for how manufacturers can use ISO 14971 in claiming conformance to the essential requirements.

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