First lists of harmonized standards published for Regulations for medical devices

European Commission decision lists first standards with a presumption of conformity

The European Commission has published lists of the first standards to be harmonized under the Medical Device Regulation - 2017/745,  (MDR) - and In Vitro Diagnostic Medical Devices Regulation – 2017/746 (IVDR). The regulations have a specific role for harmonized European standards. Article 8 indicates that harmonized standards are those referenced in the Official Journal of the European Union. Devices in conformity with relevant harmonized standards, or applicable parts of standards, are presumed to be in conformity with the requirements of the Regulation covered by those standards. Additionally, the presumption of conformity also applies to system or process requirements, including those requirements relating to quality management systems and risk management. European standards that are harmonized include a European Foreword and Annex Zs that describe the relationship between the requirements of the standard and the regulatory requirements in the European Regulations that are applicable to the scope of that standard. 

The publication of the Commission Decision with the list of standards follows the acceptance of the Standardization Request by the European Standards Organizations, CEN and CENELEC.

The list of harmonized standards for the MDR is a short one, containing only five entries. These are:

• 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 11135:2014/A1:2019
• 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
• 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).

Although this is a short list, it is encouraging that the process of harmonization has started. Additions to the list are promised in future.

These first five standards are all horizontal standards applying to a wide range of medical devices. The harmonization is associated with the publication of new editions of some of the standards and with amendments to others. Four of the standards are related to the validation and routine control of sterilization and include the standards covering the most commonly applied sterilization methods – radiation and ethylene oxide.  The harmonization of EN ISO 11135:2014 for ethylene oxide sterilization through its 2019 amendment is notable as the list of harmonized standards for the Medical Devices Directive still references the 2007 edition.

The list of standards harmonised for the IVDR is even shorter with just four standards included – these are the four sterilization standards listed under the MDR above.

Manufacturers using standards to support conformity with the MDR and with the IVDR should watch out for publication of the further lists of harmonised standards. 

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development