If you are also working in medical technology, you have probably already noticed that EN ISO 13485:2016 has a new annex:
EN ISO 13485:2016+A11:2021
Since we are also an EN ISO 13485 certified development service provider, we have taken a closer look at the changes.
What has changed?
The legal framework has changed with the introduction of the MDR (Regulation 2017/745) and IVDR (Regulation 2017/746). Since ISO 13485 is an international standard, the base standard remains unchanged. 
The legal requirements to be covered are usually specified in a separate information annex of a harmonised standard (1). These annexes are then called Annex ZA, ZB, or ZZ in the European standards.
The changes therefore affect Annexes ZA and ZB and Annex A11:2021 contains these updated Annexes ZA and ZB.
Annex ZA describes the relationship between EN ISO 13485 and the MDR, Annex ZB describes the relationship with the IVDR.
EN ISO 13485 describes requirements for a quality management system, and accordingly, it does not cover all the requirements of the MDR or IVDR. Depending on your role within the MDR or IVDR, you may need to fill in the gaps. However, thanks to Annexes ZA and ZB, these are easy to find.
Best regards,
Martin Bosch
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(1) https://eur-lex.europa.eu/legal-content/DE/TXT/PDF/?uri=CELEX:52016XC0726(02)The Blue Guide describes in more detail what “harmonised” means in the context of standards.
(2) https://www.beuth.de/de/norm/din-en-iso-13485/332674603, Link to the Beuth Verlag website with the new edition DIN EN ISO 13485:2021-12.