The following commission implementing decisions on the harmonised standards for medical devices drafted in support of the Medical Devices Regulation (EU) 2017/745 (MDR) of the European Parliament and of the Council have been published thus far:
- Commission Implementing Decision (EU) 2022/6 of 4 January 2022 as regards harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment
- 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
The following commission implementing decisions on the harmonised standards for medical devices drafted in support of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) of the European Parliament and of the Council have been published thus far:
- Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer and requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
- 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
About commission Implementing decisions
A commission implementing decision is a legally binding act of the European Union directly applicable in all member states of the EU.
Implementing decisions:
- can address specific legal entities, in which case it is binding only to them
- are always limited in scope. Their aim is to ensure uniform implementation of European legislation, and the subject-matter of any implementing decision serves that goal alone
- are directly applicable and need not be transposed into national legislation
- take precedence over national legislation in case the two contradict one another
- can only be issued when European legislation stipulates further measures are called for to ensure proper (and often uniform) implementation of said legislation by the member states
- deal with very specific issues and often address highly technical details of legislation. Often, implementing decisions address specific legal entities.
Article 8(1) of the MDR and the IVDR
In accordance with Article 8(1) of Medical Devices Regulation (EU) 2017/745 (MDR) and of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) of the European Parliament and of the Council, devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the requirements of those Regulations covered by those standards or parts thereof.
References of harmonised standards (MDR)
The references of harmonised standards for medical devices drafted in support of Medical Devices Regulation (EU) 2017/745 and listed in the Annex to these Decisions are hereby published in the Official Journal of the European Union.
They are as follows:
| Commission implementing decision | |
| Commission implementing decision (EU) 2022/6 of 4 January 2022 as regards standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment. | |
| Number | References of the standard |
| 14 | 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’. |
| 13 | 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) |
| 12 | 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) |
| 11 | EN ISO 14160:2021 Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives – Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020) |
| 10 | EN ISO 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021) |
| 9 | EN ISO 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021) |
| 8 | 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 |
| 7 | EN ISO 10993-12:2021 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021) |
| 6 | 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) |
| Commission implementing decision | |
| 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 | |
| Number | References of the standard |
| 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) |
| 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) |
| 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 |
| 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 |
| 1 | EN ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021) |
References of harmonised standards (IVDR)
The references of harmonised standards for medical devices drafted in support of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and listed in the Annex to these Decisions are hereby published in the Official Journal of the European Union.
They are as follows:
| Commission implementing decision | |
| Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer and requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples | |
| Number | Reference of the standard |
| 9 | EN ISO 17511:2021 In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020) |
| 8 | 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 |
| 7 | EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/A11:2021 |
| 6 | EN ISO 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021) |
| 5 | 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 |
| Commission implementing decision | |
| 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 | |
| Number | References of the standard |
| 4 | 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) |
| 3 | 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) |
| 2 | 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 |
| 1 | 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 |
Further information
Further information on harmonised standards is available in MDCG 2021-5 Guidance on standardisation for medical devices