The New Year saw the European Commission (EC) publish a second batch of harmonised standards under the EU Medical Devices Regulation (MDR).
Commission Implementing Decision (EU) 2022/6, released on 4 January 2022, amends the earlier Implementing Decision (EU) 2021/1182 published in July 2021. It introduces a further nine harmonised standards that medical device manufacturers should reference to satisfy conformity requirements under the MDR (see Article 8).
These latest standards cover a range of topics, including but not limited to, quality management systems; biological evaluation; sterilisation; aseptic processing and the use of symbols on product information. They supplement five standards already recognised under (EU) 2021/1182, bringing the total number of standards harmonised under the MDR to 14. A complete, up-to-date list is provided below.
| Published under Implementing Decision (EU) 2021/1182, 16 July 2021 | |
| 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) |
| Published under Implementing Decision (EU) 2022/6, 4 January 2022 | |
| 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 |
| 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. |
One notable omission is EN ISO 14971:2019, Medical Devices—application of risk management to medical devices. While this important standard is not currently harmonised (i.e. not published in the Official Journal), the version awaiting harmonisation, EN ISO 14971:2019+A11:2021, includes two informative Annexes that are an integral part of the standard. Annex ZA and ZB describe the relationship between the clauses of EN ISO 14971 and the General Safety and Performance Requirements (GSPR) of the MDR.
In readiness for MDR submissions, manufacturers should familiarise themselves with EN ISO 14971:2019+A11:2021, which provides a helpful roadmap to how risk management links to Annex I of the MDR.
The number of harmonised standards under the MDR remains relatively low compared to those previously harmonised under the Medical Devices Directive (MDD). There is an expectation that additional standards will be published by the EC during 2022.
How Can NAMSA Help?
- Do you have devices that are affected by the standards harmonised under the MDR?
- Are your devices in conformity with these harmonised standards?
- Are you using the correct, state of the art symbols on the information provided with your device?
- Do you manufacture your devices under aseptic conditions?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device and IVD development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for manufacturers. In fact, many of our Associates have previously held positions within these organizations, which provides Clients the benefit of a clearer understanding on how to proactively plan for international requirements and expectations.
To learn about NAMSA’s full suite of Regulatory and Quality services and solutions, including MDR compliance planning, please visit: https://namsa.com/services/regulatory-and-quality-consulting/ .
We also invite you to access our complimentary MDR and IVDR Planning Resources, here.
David Mandley, PhD
David joined the Regulatory Consulting Team at NAMSA in 2021 and currently serves as a Principal Regulatory Consultant. Mr. Mandley has more than 20 years’ experience in the medical device industry working with a range of product types and organisations from university spin-outs to multinationals. Following completion of his doctoral research in Applied Photochemistry at Loughborough University, David held various roles for a UK-based SME, Tissuemed, including Research & Development, QA, RA—culminating into serving as CEO for eight years. During this period, David was pivotal in the development, regulatory approval and commercialisation of a range of implantable, resorbable surgical sealants indicated as adjuncts for the prevention of intra- and post-operative leaks, including air, blood and cerebral spinal fluid. More recently, Mr. Mandley has worked as a regulatory consultant for a range of multinational medical device manufacturers, leading MDR submissions for a variety of device types and classifications (I – III) from wound care devices and their accessories, combination products and radiofrequency ablation systems.