Changes, whether they be changes to the design or changes to harmonised standards must be addressed in a timely manner. The Manufacture’s QMS must ensure that devices in production remain in conformity. The first half of paragraph 1 of Article 10, 9 is concerned with change management. However, in addition, the authors of the EU MDR have highlighted some specific EU requirements items which must be present for the QMS to be EU MDR compliant. Nevertheless, one can see that the QMS requirements in the regulation largely correspond to the sections of the Standard. At the time of writing an update of Annex Z of the Standard, the explanation of the relationship between the Standard and the Regulation, is still anticipated. On this page “the Standard” means EN ISO 13485:2016. Those familiar with the EU’s medical device QMS standard, EN ISO 13485:2016, should immediately recognise the similarities with Article 10, 9. The requirements for the Manufacturer’s Quality Management System (QMS) are contained in Article 10, 9.
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