IVDR: Harmonised standards for QMS and risk management

May 26, 2022, is an important date for all stakeholders of the IVD sector. The new Regulation on in vitro diagnostic medical devices (IVDR) will become applicable! From this date, manufacturers of IVD medical devices have to comply with the new Regulation, either fully or with certain provisions only (legacy devices). Consequently, a notification under IVDD is possible only until that date. With the new Regulation, the European Commission also published harmonised standards in support of IVDR.

Assessment of new standards

On May 12, 2022, the Commission implementing Decision on harmonised standards for quality management systems and for application of risk management of IVD 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 review the existing harmonised standards.

Publication of harmonised standards and application

Considering the new IVD 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 new IVDR. Specifically, a previous publication of the Official Journal lists the references of harmonised standards drafted in support of the IVDR. However, to include the reference of the corrigendum to standard EN ISO 13485:2016/AC:2018, it is important to consult corrigendum in Implementing Decision (EU) 2021/1195.

In our MDlaw Library, you can find all official publications on harmonised standards.

Do you want to stay always up to date? Contact us!

Leave a Reply

Your email address will not be published.