Are there any specific items in MDR / IVDR with regards to QMS that you need to know to succeed in the audit that is over and over ISO 13485:2016?
In fact, you need to integrate into your QMS certain processes such as clinical evaluation, risk management, post-market surveillance, and assignment of unique device identification which are not included into the ISO 13485-2016 requirements.
Since most manufacturers have already procedures for these processes, they have to integrated into their QMS to be compliant.
Manufacturers need to have on hand for the Audit the Amendment A11 to ISO 13485:2016 (EN ISO 13485:2016/A11:2021 - Medical devices - Quality management systems -
Requirements for regulatory purposes (ISO 13485:2016)
It includes Annexes ZA and ZB that link the standard to the requirements of Regulations 2017/745 (on medical devices) and 2017/746 (on in vitro diagnostic medical devices).
The Annexes ZA and ZB compares ISO 13485 to the requirements of Regulation (EU) 2017/745 & 2017/746 stated in Article 10 (General obligations of the manufacturers), in Annex IX and XI (Quality Management System Requirements in the conformity Assessment Annexes).
There are two important notes in annex ZA and ZB
Risks must be reduced as much as possible, but the idea of the regulation is more to control the risks according to the state of the art, not more.
The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the MDR and 1, 2, 3, 4, 5, 8, 9, 10, 11, 13, 15, 16,17, 18 and 19 of the IVDR.