What harmonised standards apply to the product?
Products manufactured in accordance with harmonised standards shall enjoy a presumption of conformity with the relevant requirements of the regulations in the area covered by the standard. Demonstration of conformity with harmonised standards shall be the recommended and most accessible form of demonstration of conformity with the general safety and performance requirements (GSPR) of the MDR Regulation or IVDR Regulation.
Although compliance with the requirements of harmonised standards is not mandatory, failure to comply with them may raise doubts as to the design of the medical devices based on the latest state of the art and cause increased risks associated with the use of the device.
Examples of harmonised standards with EU 2017/745 (MDR) and EU 2017/746 (IVDR)
- EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes,
EN ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements,
EN 285:2015+A1:2021 Sterilization – Steam sterilizers – Large sterilizers,
- EN ISO 14971:2019 Medical devices – Application of risk management to medical devices.
European Commission published the implementing decision amending the list of harmonized standards under MDR.
Up-to-date list of harmonised standards you can find on the European Commission website: