First standards harmonized with regulation 2017/745

The European Commission, almost two months after the application of Regulation 2017/745 on medical devices, has prepared an important document for manufacturers and other market participants on the harmonization of the first standards. Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on harmonized standards for medical devices developed for the purposes of Regulation (EU) 2017/745 of the European Parliament and of the Council includes a list of 5 standards:

1. EN ISO 10993-23:2021 – Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021)
2. EN ISO 11135:2014 – Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) EN ISO 11135:2014/A1:2019
3. EN ISO 11137-1:2015 – Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) EN ISO 11137-1:2015/A2:2019
4. EN ISO 11737-2:2020 – Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
5. EN ISO 25424:2019 – Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)

In the coming months, the publication of further harmonization decisions should be expected, as it has been known for a long time that the queue of standards for harmonization is very long. In accordance with the Commission Implementing Decision M / 575 of 14.4.2021, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) were asked to review the existing harmonized standards and develop new harmonized standards for the purposes of Regulation (EU) 2017/745 in on medical devices and Regulation (EU) 2017/746 for in vitro diagnostic medical devices. According to the published document, the bodies responsible for standardization are to verify 277 standards, and the deadline for their implementation was set by the Commission on May 27, 2024. Both for manufacturers of medical devices and notified bodies, the next two years will be marked by increased work on the verification of possible changes in standards related to medical devices. Therefore, we invite you to take advantage of CeCert’s services in the area of ​​training and evaluation of documentation of medical devices.

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