The general obligations of the manufacturer in article 10 (Tables ZA1 for MDR and ZB1 for IVDR).The annex maps requirements in the MDR and IVDR regulations on: This amendment features new annexes ZA and ZB that link the requirements of the MDR and IVDR, respectively, to specific clauses of the standard.
On the 9 th of September 2021, the 2021 amendment, EN ISO 13485:2016+A11:2021, was published by the European standards bodies, CEN and CENELEC.
