July 19th and 20th, 2021, “COMMISSION IMPLEMENTING DECISION (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council” and “COMMISSION IMPLEMENTING DECISION (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council” were published in the Official Journal of the European Union (OJEU).
This first publication of harmonised standards in support of MDR contains 5 references of EN ISO harmonised standards:
- EN ISO 10993-23:2021 – Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021)
- 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 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 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)
- 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 turn, the first publication of harmonised standards in support of IVDR contains 4 references of EN ISO harmonised standards, the same as those mentioned above for MDR with the exception of EN ISO 10993-23:2021.
This list of harmonised standards will be regularly enlarged and updated, according to the development of the standardisation work at international and European levels, and the next proposals by CEN and Cenelec, usually each three months.
What does this mean to you?
These lists contain the first harmonised standards in support of MDR or IVDR. As explained in MDCG 2021-5, the role of harmonised standards is key in implementing legislation because for product characteristics, the content of legislation is limited to establishing essential requirements that products intended to be placed on the EU market must meet. The technical details and solutions supporting those essential requirements are laid down in harmonised European standards. Products designed and manufactured according to applicable harmonised European standards the references to which are published in the OJEU benefit from a presumption of conformity with the relevant legal requirements. In other words, the use of harmonised standards cited in the OJEU confers presumption of conformity of the product
with the legal requirements the standard aims to cover. Nevertheless, the use of harmonised standards is voluntary.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
