The much anticipated amendment to EN ISO 13485:2016 has now been published in the form of A11:2021, providing manufacturers with updated Annexes ZA and ZB to reflect the obligations and requirements of the new EU Regulations for medical devices and IVDs.
The EU Regulations clearly stipulate that all medical device manufacturers shall have a Quality Management System (QMS) in line with the Article 10 obligations within the Regulations. Devices requiring Notified Body intervention will also need to meet QMS requirements within their appropriate conformity assessment procedures, as laid out in Annex IX or Annex XI. Once the standard is cited within the Official Journal of the European Union for that Regulation, compliance with the normative references given in Annexes ZA and ZB of the standard, presumption of conformity with the corresponding Regulation and EFTA Regulations may be conferred.
EN ISO 13485:2016+A11:2021 compares the QMS requirements of Article 10 and Annexes IX and XI with the corresponding requirements of the ISO 13485:2016 standard, providing notes on whether these are covered by the standard or not. One could thus follow these notes in order to identify those areas of their QMS which will need to be updated with respect to the EU Regulations.
We would recommend that all manufacturers who are using an ISO 13485 compliant QMS to purchase this amendment and go through Annexes ZA or ZB as appropriate in order to determine which elements of the QMS will need to be revised in order to comply with the requirements of the MDR or IVDR.
Advena can conduct a comprehensive gap analysis on your existing QMS documentation in order to highlight any deficiencies with respect to the EU Regulations and ensure your system is compliant. Our Gap Analysis Reports also provide recommendations on how these gaps may be resolved as well as tips on how to improve your QMS.