The Commission of the European Union (EU) has updated the list of standards that can use to demonstrate the biological safety of medical devices under the EU’s Medical Device Regulation ((EU) 2017/745, or the MDR).
Published during the first week of January in the Official Journal of the European Union, Commission Implementing Decision (EU) 2022/6 adds nine additional standards to the Annex of the EU’s Implementing Decision (EU) 2021/11182, which lists the harmonized standards that can be used to demonstrate conformity with the requirements of the MDR. The newly added standards include:
- ISO 10993-9:2021, Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products
- ISO 10993-12:2021, Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
- ISO 11737-1:2018, Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products
- ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes