On March 6, 2024, the European Commission amended Implementing Decision (EU) 2021/1182 on harmonised standards for single-use medical gloves, biological evaluation of Medical Devices, sterilisation of healthcare products, packaging for terminally sterilised Medical Devices and packaging for healthcare products.

By Implementing Decision C (2021) 2406 (5), the European Commission requested the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) to review the existing harmonised standards on Medical Devices drafted in support of Directives 90/385/EEC and 93/42/EEC and also requested that new harmonised standards be drafted in support of Regulation (EU) 2017/745.

As a result, CEN and Cenelec have revised the harmonised standards EN 455-3:2015 on single-use medical gloves, EN ISO 10993-15:2009, EN ISO 10993-17:2009 and EN ISO 10993-18:2020 on biological evaluation of Medical Devices, EN ISO 11137-2:2015 on sterilisation of healthcare products, EN ISO 11607-1:2020 and EN ISO 11607-2  2020 on packaging for terminally sterilised Medical Devices, and EN ISO 17664:2017 on packaging of health care products, the references of which are not published in the Official Journal of the European Union, to take into account the latest technical and scientific advances and the need to support the requirements of Regulation (EU) 2017/745.

The alignment by a manufacturer to a harmonised standard, as we know, is a very important aspect because it confers a presumption of conformity to the essential requirements.

With this initiative, the European Commission once again demonstrates its commitment to ensuring an increasing number of harmonised standards to help manufacturers produce devices that comply with safety and performance requirements to safeguard the health of users and patients.

>>> Through the services of strategic-regulatory consulting, support to EC certification and if necessary, a European Authorised Representative, Thema can help you implement the requirements of the MDR (EU) 2017/745.