Newly Published Harmonized Standards for MDR and IVDR Compliance

On March 8th, 2024, “Commission Implementing Decision (EU) 2024/815 of March 6th, 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for “medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products” and “Commission Implementing Decision (EU) 2024/817 of March 6th, 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for “sterilisation of health care products and packaging for terminally sterilised medical devices” were published in the Official Journal of the European Union (OJEU).

The Amending Regulation 2024/815 has added the following entries in the Annex to the Implementing Decision (EU) 2021/1182, reaching 25 references overall:

No	Reference of the standard
18.	EN 455-3:2023 Medical gloves for single use – Part 3: Requirements and testing for biological evaluation
19.	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)
20.	EN ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
21.	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
22.	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
23.	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
24.	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
25.	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)’.

The Amending Regulation 2024/817 has added the following entries in the Annex to the Implementing Decision (EU) 2021/1195, reaching 13 references overall:

No	Reference of the standard
11.	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
12.	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
13.	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’.

What Does This Mean To You?

As explained in MDCG 2021-5, the role of harmonized standards is key in implementing legislation because for product characteristics, the content of legislation is limited to establishing essential requirements that products intended to be placed on the EU market must meet. The technical details and solutions supporting those essential requirements are laid down in harmonized European standards. Products designed and manufactured according to applicable harmonized European standards the references to which are published in the OJEU benefit from a presumption of conformity with the relevant legal requirements. In other words, the use of harmonized standards cited in the OJEU confers presumption of conformity of the product with the legal requirements the standard aims to cover. Nevertheless, the use of harmonized standards is voluntary.

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