EN ISO 13485 now linked to MDR/IVDR

CEN has now published EN ISO 13485:2016+A11:2021, ‘Medical devices – Quality management systems – Requirements for regulatory purposes’, adding Annex Zs to the already published standard.

It is expected that the European Commission will add EN ISO 13485:2016+A11:2021 to the slowly growing list of standards harmonized under the Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostics Regulation (IVDR, 2017/746) before the end of 2021, which would then allow device manufacturers to claim a presumption of conformity with identified clauses of the regulations.

Specifically, the new Annexes link clauses of the standard with:

• The general obligations of the manufacturer in MDR/IVDR Article 10;
• The quality management system (QMS) requirements in MDR/IVDR Annex IX on conformity assessment based on a QMS and on assessment of technical documentation; and
• The QMS requirements in MDR/IVDR Annex XI on conformity assessment based on product conformity verification.

The current list of standards harmonized under the MDR/IVDR can be accessed here.