On 9 October 2024, the European Commission published new harmonised standards in support of the EU medical devices Regulations (MDR and IVDR). These new standards are the results of a revision of previous harmonised standards from 2021.
- Commission Implementing Decision (EU) 2024/2625 of 8 October 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for aseptic processing of health care products and clinical performance studies using specimens from human subjects
- Commission Implementing Decision (EU) 2024/2631 of 8 October 2024 amending Implementing Decision (EU) 2021/1182 as regards the harmonised standard for aseptic processing of health care products
MDR: aseptic processing of health care products and clinical performance studies using specimens from human subjects
In the Annex to Implementing Decision (EU) 2021/1195, the following entries are added:
IVDR: Aseptic processing of health care products
In the Annex to Implementing Decision (EU) 2021/1182, the following entry is added:
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