Progress Update: Commission Proposal to Extend the IVDR Transition Period & Rollout EUDAMED
28 May 2024
GMDN Agency: Training and Q&A Workshops Scheduled for Manufacturers and Regulators
11 June 2024The list of pending EU harmonized standards was newly updated. It was originally published 14 April 2021 and subsequently amended 31 January 2023 and 27 May 2024.
Please find the links below:
Overview
The European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are requested to:
- Revise existing standards to meet the MDR/IVDR:
- Annex I, Table 1 (medical devices), and
- Annex II, Table 1 (IVDs).
- Draft new standards to support the MDR/IVDR:
- Annex I, Table 2 (medical devices), and
- Annex II, Table 2 (IVDs).
The consolidated list reflects:
- Harmonised Standards already released, e.g., EN ISO 15223-1:2021 general requirements on medical device symbols & EN ISO 14971:2019 on risk management
- Harmonised Standards not yet completed by the original proposed date of 27 May 2024 and therefore remain as pending action items
- New work items requested
The deadline to complete the new work items is 27 May 2028.
EU Harmonized Standards Work List
Medical Devices – Annex I
Table 1 of the consolidated list contains 226 standards, which are pending revision to meet the MDR. This is in comparison to the original list of 201.
Table 2 of the consolidated list contains 51 standards, newly requested. This is in comparison to the original list of 27.
The total number of work items under the MDR is 277.
IVDs – Annex I
Table 1 of the consolidated list contains 45 standards, which are pending revision to meet the IVDR. This is in comparison to the original list of 46.
Table 2 of the consolidated list contains 4 standards, newly requested. This is in comparison to the original list of 3.
The total number of work items under the IVDR is 49.
Further Reading
The following topics may also be of interest:
