Brigid beat me to it. She did a nice job of explaining her take each of the 7 issues that the EU Commission has with the ISO 14971 Standard.

QA Kiwi

Have you performed a gap analysis on your Risk Matrix against the MDD requirements?

No you don’t need to buy EN ISO14971:2012, but if you have an EU certificate and must comply with the EU Medical Devices Directive, then you must apply the EU requirements for risk management, spelled out in the new annexes. This version of 14971 was accepted as an EU harmonised standard in August 2012 and therefore applies now. The EU requirements aren’t new, but it has been common for companies to apply 14971 without noticing that there are some subtle differences in the Essential Requirements. The EN standard spells them out for us.

A copy of the annexes is available  here from the Danish Standards website. We are grateful to them for acknowledging that this is more about regulation than it is about standards.

While none of the requirements are new, they will impact on how your…

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