Breaking news: European Commission published second batch of harmonised standards under MDR
On January 4, the European Commission recognised nine harmonised standards for medical devices that manufacturers can reference in order to satisfy conformity requirements under the Medical Devices Regulation (MDR 2017/745).
These standards follow an earlier set of five standards that the commission recognised in July 2021, bringing the total number of harmonised standards to fourteen.
Harmonised standards are a kind of elaboration on parts of – in this case – the MDR, helping manufacturers to comply with the MDR more easily and quickly. The MDR is limited to establishing essential requirements that medical devices 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.
When a harmonised standard has been approved and published by the European Commission and a medical device is in conformity with that standard or the relevant parts of that standard, the device is presumed to be in conformity with the MDR. If a manufacturer uses harmonised standards, the conformity assessment procedure of the device concerned will therefore be much faster and more efficient.
However, manufacturers are not obliged to use harmonised standards. In general they are allowed to use other standards or develop their own technical solutions, provided that they must be able to demonstrate that these alternatives meet the requirements of the MDR.
Harmonised standards under the MDR
The fourteen standards cover topics including the biological evaluation of medical devices, sterilisation, aseptic processing, quality management systems, the use of symbols in product information, and more. They apply to a wide variety of medical devices:
EN ISO 10993-23:2021
Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021)
EN ISO 11135:2014
Sterilisation of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilisation process for medical devices (ISO 11135:2014)
EN ISO 11135:2014/A1:2019
EN ISO 11137-1:2015
Sterilisation of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
EN ISO 11137-1:2015/A2:2019
EN ISO 11737-2:2020
Sterilisation of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilisation process (ISO 11737-2:2019)
EN ISO 25424:2019
Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 25424:2018)
EN ISO 10993-9:2021
Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
EN ISO 10993-12:2021
Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
EN ISO 11737-1:2018
Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
EN ISO 11737-1:2018/A1:2021
EN ISO 13408-6:2021
Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021)
EN ISO 13485:2016
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
EN ISO 13485:2016/A11:2021
EN ISO 14160:2021
Sterilisation of health care products – Liquid chemical sterilising agents for single-use medical devices utilising animal tissues and their derivatives – Requirements for characterisation, development, validation and routine control of a sterilisation process for medical devices (ISO 14160:2020)
EN ISO 15223-1:2021
Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021
EN ISO 17664-1:2021
Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
EN IEC 60601-2-83:2020
Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment (EN IEC 60601-2-83:2020/A11:2021)
EN IEC 60601-2-83:2020/A11:2021
Do you have any questions about this article or the harmonised standards discussed here? Or would you like to know more about the MDR conformity assessment procedure? Please contact our experts. We will be happy to answer your questions.