Early September 2021, the 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 ISO 13485:2016 standard.
EN ISO 13485:2016+A11:2021 amends EN ISO 13485:2016, incorporating corrigenda March 2016, December 2016 and 2018, with a revised European Foreword and European Annexes ZA and ZB.
Annex ZA addresses the relationship between the EN ISO 13485:2016 and the requirements of Regulation (EU) 2017/745 (MDR) with regards to the general obligations of the manufacturer in Article 10 (covered in Table ZA.1), the quality management system requirements in Annex IX on conformity assessment based on a quality management system and on assessment of technical documentation (covered in Table ZA.2) and quality management system requirements in Annex XI on conformity assessment based on product conformity verification (covered in table ZA.3).
Annex ZB addresses the relationship between the EN ISO 13485:2016 and the requirements of Regulation (EU) 2017/746 (IVDR) with regards to the general obligations of the manufacturer in Article 10 (covered in Table ZB.1), the quality management system requirements in Annex IX on conformity assessment based on a quality management system and on assessment of technical documentation (covered in Table ZB.2) and quality management system requirements in Annex XI on conformity assessment based on production quality assurance (covered in table ZB.3).
It is important to take note that the primary goal of ISO 13485:2016 is not to cover exactly the European quality management system requirements as it is intended to be applicable in jurisdictions all over the world. Consequently, conformity is not entirely achieved by complying only with the requirements specified in EN ISO 13485. Manufacturers, and other economic operators, will need to integrate the quality management system requirements in the applicable European Regulation into the processes provided by EN ISO 13485. In addition, the European Regulations require the incorporation of certain processes in the quality management system, such as performance evaluation, risk management, post-market surveillance, and assignment of unique device identification. EN ISO 13485 requires the integration of these processes into the quality management system in accordance with regulatory requirements but does not explicitly include the details of the European Union regulatory requirements within the standard.
What does this mean to you?
Even though ISO 13485:2016 is not mandatory for EU MDR/IVDR compliance, it is a generally accepted standard to demonstrate compliance to the MDR/IVDR requirement of having a QMS implemented. It is thus highly recommended that manufacturers, authorized representatives, importers, and distributors in the EU apply this standard.
Once the standard is published as harmonized in the Official Journal of the EU, manufacturers who comply with the EN ISO 13485:2016+A11:2021 can claim that they also comply with the requirements in the new regulations with which they are linked.
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