In our previous blog post, we set out the Commission's proposed amendments to the Medical Devices Regulations (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulations (EU) 2017/746 (IVDR). The new Regulation introducing these changes has now been published: Regulation (EU) 2024/1860.
The new Regulation includes a welcome extension to the transitional periods for certain IVDs under the IVDR, where applicable conditions have been met. The other proposals relate to a gradual roll-out of Eudamed and notification obligations for interruptions in supply.
IVDR transitional periods extension
As a reminder, the European Parliament and Council adopted a staggered extension of the IVDR transitional periods back in January 2022. The transitional periods have now been extended once again, in light of the limited capacity of Notified Bodies to undertake conformity assessments and an on-going concern that there will be a shortage of essential high-risk IVDs (the transitional period for these was due to end on 26 May 2025).
The new transitional periods have been implemented as per the Commission's proposals, details of which are in our previous blog linked above, including all applicable conditions which must be met for the extensions to apply.
In summary, the dates have changed as follows:
| Class of IVD | Previous extension | New extension |
|---|---|---|
| IVDs with a certificate under the IVDD | May 2025 | 31 December 2027 (subject to certain conditions) |
| Class D | May 2025 | 31 December 2027 |
| Class C | May 2026 | 31 December 2028 |
| Class B | May 2027 | 31 December 2029 |
| Class A (sterile) | May 2027 | 31 December 2029 |
| Class A (do not require notified body certification) | May 2022 | May 2022 (no change) |
| New devices not on the market under the IVDD | May 2022 | May 2022 (no change) |
A word on the UK
While the MDR and IVDR do not apply in the UK, the UK currently continues to recognise CE marking, allowing EU authorised devices to be placed on the GB market. The transitional arrangements are set out in the MHRA's publication 'Implementation of the Future Regulations'. The extension of the IVDR transitional periods now outdates the MHRA's timelines for placing CE marked IVDs on the GB market. No updated guidance has been published by the MHRA on this, though it seems likely that this will follow soon.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
