New EU pilot programme for breakthrough medical devices and in vitro diagnostics

This pilot programme is intended to build on the guidance on breakthrough medical devices and IVDs (hereafter, “breakthrough technologies”) issued by the Medical Device Coordination Group (“MDCG”) last December (see here: MDCG 2025-9). The experience resulting from this programme will contribute to shape the possible future legal framework for breakthrough technologies as included in the European Commission’s proposal presented last December for the revision of the MDR and IVDR (see here). This proposal recognises a regulatory gap, noting that the current framework lacks sufficient support and dedicated pathways for breakthrough technologies. Accordingly, the proposal introduces adaptive certification procedures for these technologies (see new Articles 52a of the MDR and 48a of the IVDR) and enables manufacturers to seek advice from expert panels, a mechanism that will now be tested through the pilot programme.

A medical device or IVD may be considered a breakthrough technology if it meets both of the following criteria (see section 4.1 of guidance MDCG 2025-9 and new Articles 52a(2) of the MDR and 48a(2) of the IVDR): 

• Novelty: it is expected to introduce in the EU a high degree of novelty with respect to the device technology, related clinical procedure or the application of the device in clinical practice; and
• Positive clinical impact: it is expected to provide a significant positive clinical impact on patients or public health, for a life-threatening or irreversibly debilitating disease or condition, by either of the following: (i) offering a significant positive clinical or health impact compared to available alternatives and the state of the art; or (ii) fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose.

To access the pilot programme, manufacturers will first need to request an opinion from the relevant expert panels on whether their products meet the criteria above to be designated as breakthrough technologies (the EMA will publish detailed guidance and templates for applicants ahead of the pilot’s launch). It is intended that medical devices and IVDs can be designated as breakthrough technologies at an early stage of their development (from months to years before they are expected to enter the EU market). Expert panels are composed of independent scientific, technical, and clinical experts and are administered by the EMA.

Where the opinion of the expert panel confirms the fulfilment of the breakthrough criteria, manufacturers will be able under the pilot programme to request advice from the expert panels on their planned clinical development strategy and the appropriate pre-clinical or clinical data for the clinical evaluation of the concerned medical devices (or, for the case of IVDs, request advice on their performance evaluation strategy and appropriate analytical or clinical performance data for the performance evaluation of the relevant IVDs). The MDCG 2025-9 guidance states that the request for opinion may also cover proposed post-market clinical follow-up (“PMCF”) activities where relevant to the demonstration of ongoing safety and performance.

Ahead of the launch of the pilot, the EMA will hold an online information session on 24 April where further practical considerations for manufacturers intending to participate in the programme will be clarified (registration and the agenda are available here).

This pilot programme supports the European Commission’s objective, as reflected in the MDR and IVDR revision proposals, to improve the cost-effectiveness and overall competitiveness of the EU medtech industry by supporting innovation, while ensuring a high level of protection of health.

Authored by Cláudia Mendes Pinto.