Once reference to this standard is published in the Official Journal of the European Union and therefore it is officially harmonized, compliance with its clauses will grant a presumption of compliance to the corresponding requirements of the MDR/IVDR. With this in mind and now the publication of this amendment explaining the relationship between EU MDR/IVDR requirements and the standard, we highly recommend manufacturers, authorized representatives, importers, and distributors in EU to apply this standard.ĮN ISO 13485:2016+A11:2021 provides regulatory requirements for your QMS that ensures consistent design, development, production, installation, and delivery of medical devices. Why is this amendment important for you as an Economic Operator?Īlthough ISO 13485:2016 is not mandatory for EU MDR/IVDR compliance, it is a commonly acknowledged standard to demonstrate the compliance to the MDR/IVDR requirement of having a QMS implemented. Number of Pages: 46 File Size: 1 file, 420 KB Redline File Size: 2 files, 1 MB Same As: DIN EN ISO 13485, CAN/CSA-ISO 13485:16, BS EN ISO 13485:2016 Document History. The standard was last revised in 2016 and in 2021 was confirmed for a further five (5) years.
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