Revision ISO 13485:2016+A11:2021
The ISO 13845:2016 standard was revised and published by the European standardization bodies CEN and CENELEC in September 2021. The ISO 13485:2016+A11:2021 includes new annexes that align the requirements of the Medical Devices Regulation) and IVDR (In Vitro Diagnostic Medical Devices Regulation) with specific clauses of the standard.