Harmonised standards for medical devices and in vitro diagnostic devices

A reference to other EN standards harmonised to the MDR and IVDR has been published in the Official Journal of the EU.

The list of standards can be found in the annexes to the Commission Implementing Decisions under the following links:

Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of healthcare products, aseptic processing of healthcare products, quality management systems, marks to be used with information provided by the manufacturer, processing of healthcare products and home light therapy devices

Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for the sterilisation of healthcare products, aseptic processing of healthcare products, quality management systems, marks to be used with information provided by the manufacturer and requirements for establishing the metrological continuity of values assigned to calibrators, truth control materials and human samples