On the 9th of September 2021, the 2021 amendment, EN ISO 13485:2016+A11:2021, was published by the European standards bodies, CEN and CENELEC. This amendment features new annexes ZA and ZB that link the requirements of the MDR and IVDR, respectively, to specific clauses of the standard.
What is new?
The annex maps requirements in the MDR and IVDR regulations on:
- The general obligations of the manufacturer in article 10 (Tables ZA1 for MDR and ZB1 for IVDR)
- The quality management system requirements in Annex IX on conformity assessment based on a quality management system and on assessment of technical documentation (Table ZA2 for MDR and ZB2 for IVDR)
- The quality management system requirements in Annex XI on conformity assessment based on product conformity verification (Table ZA3 for MDR and ZB3 for IVDR)
The standard was last revised in 2016 and in 2021 was confirmed for a further five (5) years.
Why is this amendment important for you as an Economic Operator?
Although 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. 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.
EN ISO 13485:2016+A11:2021 provides regulatory requirements for your QMS that ensures consistent design, development, production, installation, and delivery of medical devices. 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.