EU pilot programme for breakthrough medical devices: applications open

As we reported earlier this month (see our previous article here), the EMA had announced the upcoming launch of a pilot programme offering expert panel advice to developers of breakthrough medical devices and in vitro diagnostic medical devices (“IVDs”) in Q2 2026. The pilot programme has now been officially opened on 28 April.

A medical device or IVD may be designated a breakthrough technology if it meets the two relevant criteria relating to novelty and positive clinical impact (see our previous article, as well as section 4.1 of guidance MDCG 2025-9 and the proposed new Articles 52a(2) of the MDR and 48a(2) of the IVDR, according to the proposal for revision of these regulations).

The pilot programme is set to run in three phases:

• First phase (Ia and Ib)

The first phase of the programme, phase Ia, is now open and accepting applications until 22 May 2026 (included). Eligible medical devices for phase Ia (and later phase Ib) are:

• Class III medical devices
• Class IIb active medical devices intended to administer or remove medicinal products from the body.

The EMA has announced that it will select five applications in phase Ia and give priority to cardiovascular and paediatric devices. The first phase is expected to continue with phase Ib as of Q3 2026. Manufacturers who were not selected for phase Ia can re-submit in phase Ib.

• Second phase (II)

Phase II is expected to start in Q1 2027. In this phase, the EMA intends to extend the scope of the programme to all medical device classes.

• Third phase (III)

Phase III is expected to start in Q3 2027. In this phase, IVDs will also be covered by the scope of the programme.

Participation in the pilot programme is free. To apply, manufacturers must submit a letter of interest via a dedicated portal (more information is available here). After confirmation that their application has been selected for the pilot (for phase Ia) or in scope of the pilot (for the other phases), manufacturers must then submit a formal application (for breakthrough designation and for request for advice; templates are available on the same website).

The expert panels will assess the applications and provide an opinion on whether the concerned devices or IVDs meet the criteria for designation as breakthrough medical devices or IVDs. 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. The scope of the requested advice will depend on the product’s stage of development but may include aspects such as pre-clinical evidence generation, acceptability of intended clinical development strategy, acceptability of the proposed clinical investigations and post-market clinical follow-up activities.

The EMA has also clarified that in the first phase of the pilot, the Notified Body selected by the manufacturer will be involved in the request for advice for one of the five selected applications (the one deemed to be most advanced in its device development, meaning that the device should already be undergoing conformity assessment or close to that).

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. 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.

Authored by Cláudia Mendes Pinto