On May 11 new Harmonised Standards lists for MDR and IVDR were published in the OJEU which identified EN ISO 14971:2019+A11:2021 as Harmonised for the two regulations. Of course, there were other standards on the list as well but this one has been my main concern.
The long wait is over, and the diligent efforts of the CEN Technical Committee to get this standard Harmonised have paid off. I personally want to congratulate the TC and thank them for their tireless efforts which started over three years ago to get this job done.
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ Fellow, and Member ISO TC 210 JWG1
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.comPrincipal Consultant
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