Harmonised Standards under EU MDR / IVDR: EC Publishes New Implementing Decisions (EU) 2024/815 and (EU) 2024/817
11 March 2024
Harmonised Standards for Medical Devices: Further Amendment of Implementing Decision (EU) 2021/1182
On 8 March 2024, Commission Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for single-use medical gloves, biological evaluation of medical devices, sterilization of healthcare products, packaging for medical devices to be sterilized in the final packaging and reprocessing of healthcare products was published in the Official Journal of the European Union.
A total of four new references were added to the existing list of harmonised standards and four existing references were revised in the process:
- EN 455-3:2023 Medical gloves for single use – Part 3: Requirements and testing for biological evaluation
- EN ISO 10993-15:2023 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
- EN ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
- EN ISO 10993-18:2020 Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020); EN ISO 10993-18:2020/A1:2023
- EN ISO 11137-2:2015 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013); EN ISO 11137-2:2015/A1:2023
- EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); EN ISO 11607-1:2020/A1:2023
- EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); EN ISO 11607-2:2020/A1:2023
- EN ISO 17664-2:2023 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices (ISO 17664-2:2021)
There are a total of 25 harmonised standards under the MDR.
Harmonised Standards for In Vitro Diagnostic Medical Devices: Amending Implementing Decision (EU) 2021/1195
Commission Implementing Decision (EU) 2024/817 of 6 March 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilization of healthcare products and packaging for medical devices to be sterilised in the final packaging was published in the Official Journal of the European Union on 8 March 2024.
Revised references include:
- EN ISO 11137-2:2015 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013); EN ISO 11137-2:2015/A1:2023
- EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); EN ISO 11607-1:2020/A1:2023
- EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); EN ISO 11607-2:2020/A1:2023
There are a total of 13 harmonised standards under the IVDR.
