MDR: Harmonised standards for QMS and risk management

Since May 26, 2021, the medical device sector experienced a great change. The new Regulation replaced the previous Directive and from that date, manufacturers of medical devices have to comply with the new Regulation, either fully or with certain provisions only (legacy devices). With the new Regulation, the European Commission also published harmonised standards in support of MDR.

Assessment of new standards

On May 17, 2022, the Commission implementing Decision on harmonised standards for quality management systems and for application of risk management of medical devices was published in the Official Journal of the European Union. Previously, the Commission requested to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) to draft new harmonised standards.

Publication of harmonised standards and application

Considering the Medical Device Regulation and the latest technical and scientific progress, the Commission drafted new standards. The CEN and Cenelec assessment considered harmonised standard EN ISO 14971:2019 meeting the requirements set by the MDR.

Specifically, a previous publication of the Journal lists the references of harmonised standards drafted in support of Regulation (EU) 2017/745, the MDR. A new European Commission website lists harmonised standards, directing towards Summaries in support of MDR and IVDR.

In our MDlaw Library, you can find all official publications on harmonised standards as well as relevant ISO standards.

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