EU’s Risk Management Standard Officially Recognized In Context Of The IVDR

13 May 2022

Only one new standard has been added to the official list of standards recognized in the context of the EU IVD Regulation in the latest update. The good news is that it is arguably one of the most needed standards by the IVD industry after the medtech quality management standard, ISO 13485.

Risk management concept hand drawn on chalkboard

The European Commission has updated the list of standards harmonized in the context of the IVD Regulation to include the risk management standard EN ISO 14971: 2019/A11:2021, Medical devices – Application of risk management to medical devices (ISO 14971:2019).

It has done this by amending Implementing Decision (EU) 2021/1195 on the list of harmonized standards under the IVDR.