IVDR: European Commission publishes second batch of harmonized standards
On Thursday, the European Commission officially recognized five additional harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro Diagnostic Medical Devices Regulation (IVDR).The standards cover topics including sterilization, aseptic processing, quality management systems, the use of symbols in product information, and requirements for establishing metrological traceability of certain values for calibrators, control materials and human samples.
The five newly recognized harmonized standards follow an earlier set of four standards – all related to sterilization – that the Commission recognized in July 2021, bringing the total number of recognized standards to nine. The recognition of the standards follows the Commission’s request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) to revise and draft standards in support of the new regulations. (RELATED: MDR/IVDR: Commission adopts new standardization request, Regulatory Focus 16 April 2021)
In between the two batches of recognized standards, EU authorities moved to delay the implementation of certain aspects of IVDR amid fears of a market collapse due to the shortage of notified body capacity. (RELATED: IVDR: Commission proposes to delay implementation amid 'grave' notified body shortage, Regulatory Focus 14 October 2021; IVDR’s progressive rollout gets official with EU Council, Parliament adoption, Regulatory Focus 20 December 2021)
| Commission Implementing Decision (EU) 2021/1195 | |
| 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) |
| 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) |
| 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) |
| 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) |
| Commission Implementing Decision (EU) 2022/15 | |
| 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) |
| 6. | EN ISO 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021) |
| 7. | EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) |
| 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) |
| 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) |
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