ISO 14971 no longer compliant with EU requirements

A new version of EN 14971 was published and harmonized in the Official Journal of the EU. ISO 14971 now may not ensure compliance with EU essential requirements for medical devices. Specifically, 14971 allows the manufacturer to disregard negligible risks; but all risks must be taken into account and reduced as much as possible to satisfy EU requirements. “As low as reasonably practicable” is not acceptable if economic consideration is included. In addition, an overall risk-benefit analysis is always required to meet EU requirements even if it not required in some circumstances under 14971.

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