HARMONIZED STANDARDS TO SUPPORT THE EUROPEAN UNION MEDICAL DEVICES REGULATION         

The European Union (EU) has a competitive and innovative medical devices sector with over 500 000 types of medical devices and in vitro medical devices placed on its market. The EU Medical Devices Regulation (MDR – Regulation (EU) 2017/745) lays down the rules regarding the placing on the market, making available on the market or putting into service of medical devices for human use (and accessories for such devices). The Regulation (EU) 2017/746 sets out the rules on in vitro diagnostic medical devices (IVDR), as explained in our previous post.

The MDR has entered in force on May 26 this year and on July 16^th the European Commission published harmonized standards for medical devices (Commission Implementing Decision (EU) 2021/1182), to support the MDR. This Implementing Decision entered in force at the same date of its publication.

The European Committee for Standardization (CEN) revised the existing harmonized standards (EN ISO 11135:2014, EN ISO 11137-1:2015, EN ISO 11737-2:2009 and EN ISO 25424:2011) and included the latest technical and scientific progress, adapting them to the relevant requirements of the MDR. This resulted in the adoption of new harmonized standards EN ISO 11737-2:2020 and EN ISO25424:2019 and of the amendments EN ISO 11135:2014/A1:2019 to EN ISO 11135:2014 and EN ISO 11137-1:2015/A2:2019 to EN ISO 11137-1:2015. CEN drafted the new harmonized standard: EN ISO 10993-23:2021.

Together with CEN, the Commission assessed and concluded that the standards revised and drafted comply with the requirements set out in the MDR. Consequently, the references of those standards were published in the Official Journal of the European Union – Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on harmonized standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council – as followed:

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).

If you wish to get more information on the EU-MDR, do not hesitate to contact us at info@criticalcatalyst.com.

References:

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02017R0745-20200424&from=EN
2. Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on harmonized standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council. Available at: https://eur-lex.europa.eu/eli/dec_impl/2021/1182/oj