Amendment to the European Standard for Risk Management of Medical Devices
An European amendment to EN ISO 14971 - Medical devices - Application of risk management to medical devices, designated A11:2021, was published in December 2021, paving the way to the standard being listed in the Official Journal of the European Union (OJEU) as providing a presumption of conformity with the relevant requirements of the European Medical Device and In Vitro Diagnostics Regulations.
