EU MDR harmonized standards first set released
The manufacturer must justify and document the design steps of his device. He must verify compliance with the requirements of Annex I to the European Medical Device Regulation 2017/745 dedicated to general safety and performance requirements. EU MDR harmonized standards and reference requirements can be used for that purpose.
The manufacturer may benefit from a presumption of conformity if he complies with:
- harmonized standards[1] related to quality management systems, risk management, post-market surveillance system, clinical investigations, clinical evaluation and post-market clinical follow-up (PMCF),
- harmonized standards and monographs of the European Pharmacopoeia related to the device,
A harmonized standard is a European standard developed by a recognized European Standards Organisation: CEN, CENELEC, or ETSI. It is created following a request from the European Commission to one of these organizations. Manufacturers, other economic operators, or conformity assessment bodies can use harmonized standards to demonstrate that products, services, or processes comply with relevant EU legislation.
EU MDR standards can be for instance: EN ISO 13485, EN ISO 14971, EN ISO 10993-1, EN IEC 60601-1, etc…
The references of harmonized standards must be published in the Official Journal of the European Union. The purpose of this website is to provide access to the latest lists of references of harmonized standards and other European standards published in the Official Journal of the European Union (OJEU).
On July 16, 2021, a first set of EU MDR harmonized standards has been released by the European Commission. The official notification can be found here.
Only 5 standards have been approved as you can see below:
ANNEX of the implementing decision:
|
No |
Reference of the standard |
|
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) |
On January 4, 2022, another set of EU MDR harmonized standards was released by the European Commission. The official notification can be found here.
9 new standards were added to the list above as you can see below.
ANNEX of the implementing decision:
|
No |
Reference of the standard |
|
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) |
|
7. |
EN ISO 10993-12:2021 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021) |
|
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 |
|
9. |
EN ISO 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021) |
|
10. |
EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/A11:2021 |
|
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) |
|
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) |
|
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) |
|
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’. |
On May 11, 2022, another set of EU MDR harmonized standards was released by the European Commission. The official notification can be found here.
9 new standards were added to the list above as you can see below.
ANNEX of the implementing decision:
|
entry No 10 above is replaced by the following:
|
|
(2) |
the following entries are added:
|
So this brings the total of harmonized standards to 16.
Obviously, more harmonized standards will be added in the future.
[1] Article 8 Regulation 2017/745.
[2] Article 9 Regulation 2017/745.
You may go back to our EU MDR guide.
If you are interested in the European market you can contact us for a preliminary discussion. You can also look at our dedicated page for European medical device registration.
