The European version of the international medical device quality management systems standard, EN ISO 13485:2016+A11:2021, has been updated with new annexes demonstrating the link between specific clauses of the standard and the general safety and performance requirements (GSPR) of the Medical Device and IVD Regulations. It is expected to be published in the Official Journal of the EU in October, making it a "harmonized" standard. Manufacturers that follow harmonized standards are presumed to be in conformity with the requirements in the regulation with which they are linked.
Another vital standard for the medtech industry on risk management, EN ISO 14971, is also expected to be updated in the same manner very soon.
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