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:

The Commission has also published a Q&A on practical aspects related to the extended transitional period provided for in the IVDR.

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.