EN ISO 13485:2016 – Amendment 11 has been published!
The European standardisation bodies CEN and CENELEC published EN ISO 13485:2016+A11:2021 featuring new annexes ZA and ZB that link the requirements of the MDR (Regulation EU 2017/745) and the IVDR (Regulation EU 2017/746), respectively, to specific clauses of the standard.
