EN ISO 14971 2019
Two years’ back EN ISO 14971 2019 Medical Devices – Application of Risk Management to medical devices was published. Harmonized Standard EN ISO 14971 2019 has already replaced the previous standard EN ISO 14971:2012 which was only harmonized for three directives MDD, AIMDD and IVDD. There were content deviations in the Z annexes of EN ISO 14971:2012. The limitation of the coverage & the content deviation caused many problems for the manufacturer in compliance with the directives. The MDR and IVDR have significantly more comprehensive and detailed requirements for the Risk Management Process as compared to these directives.
New Z Annexes:
First of all, there are no any content deviations in the New Z Annexes of EN ISO 14971 2019 + Amd11:2021; which is a big relief. The European Amendment containing ‘New Z Annexes’ has been finally released and will be Harmonized in the First Quarter of Year 2022. The New Z Annexes are ZA and ZB. ZA and ZB annexes in EN ISO 14971 2019 + Amd11:2021 show a strong bond between the standard and the Risk management process. New Z Annexes state that the compliance with the standard gives the presumption of the conformance with the applicable GSPRs of the European Regulations MDR and IVDR.
GSPRs covered by New Z Annexes:
Z Annexes contain a Table showing which GSPRs in Annex 1 are covered i.e. Annex ZA and ZB show the relationship between the GSPRs in Annex 1 of each regulation with the clauses of Risk Management standard of Medical Devices (EN ISO 14971 2019).
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