The Medical Devices Regulation (MDR) (EU) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 include the requirements for risk management.
Compliance to risk management standards is not mandatory for CE marking medical devices under the European Medical Device Regulations (IVDR and MDR). Although it isn’t currently harmonized to the Regulations, EN ISO 14971:2019 represents the state-of-the-art for risk management.
EN ISO 14971:2012 is harmonized to the European Medical Device Directives (AIMDD, IVDD and MDD), which allows presumption of conformity to the Directives.
Manufacturers certified under the Directives may choose to comply with the harmonized 2012 version or the state-of-the-art 2019 version of the standard. Manufacturers certified under the Regulations choosing to utilize ISO 14971 should comply with the state-of-the-art 2019 version of the standard.