EMA Launches Pilot Programme for Expert Panel Support to Breakthrough Medical Devices (28 April 2026)

Key summary

• On 28 April 2026 the European Medicines Agency (EMA) officially launched the pilot programme for expert panel support to breakthrough medical devices (BtX), giving manufacturers of innovative devices and notified bodies access to free expert panel advice intended to accelerate market access for breakthrough devices.
• The pilot runs in three phases through 2027, subject to available resources. Applications for Phase Ia have closed; manufacturers selected in Phase Ia may subsequently submit requests for advice.
• Phase I covers Class III devices and Class IIb active devices intended to administer or remove medicinal products, with priority given to cardiovascular and paediatric devices.
• Manufacturers not selected in Phase Ia but considered eligible for Phase Ib must submit a breakthrough status request briefing document by 15 September 2026. Early preparation of designation and expert consultation materials is advisable.

Full translation: EMA announcement

Purpose of the pilot

The EMA's breakthrough medical device (BtX) pilot programme aims to establish a long-term process through which manufacturers and notified bodies can seek support from the medical device expert panels.

The EMA is running a pilot that provides expert panel support to manufacturers of breakthrough medical devices (BtX) and to notified bodies.

The pilot offers the following free advice:

• For manufacturers seeking designation: advice on possible breakthrough medical device status;
• For manufacturers of designated breakthrough devices and for notified bodies: additional advice on how to implement guidance issued by the Medical Device Coordination Group (MDCG).

Breakthrough medical devices are highly innovative devices that demonstrate the potential to address unmet medical needs or to offer a significant advantage over existing technology.

As part of the pilot, manufacturers seeking breakthrough designation submit requests for advice to the medical device expert panels.

The EMA launched the pilot on 28 April 2026. It operates in three phases until 2027, depending on available resources.

For Class III implantable medical devices, health technology developers and manufacturers may request parallel joint scientific advice (JSC) from the expert panel and HTA bodies simultaneously. Further details are available under the parallel joint scientific consultation with HTA Member State Coordination Group (HTACG).

Guidance on breakthrough medical device designation

Existing guidance can help determine whether a medical device may be designated as "breakthrough". The objective of designation is to accelerate market access for highly innovative medical devices and in vitro diagnostic medical devices (IVDs) while maintaining rigorous safety and performance standards.

It also provides manufacturers and notified bodies with a benchmark for the clinical evaluation of breakthrough devices, which require clinical data evidence to demonstrate conformity with the Medical Device Regulation (EU 2017/745).

The Medical Device Coordination Group (MDCG) published this guidance in December 2025 (MDCG 2025-9: Guidance on breakthrough devices under Regulations 2017/745 and 2017/746).

How the pilot works

The EMA received applications for the first part of Phase I (Phase Ia) until 22 May 2026 inclusive.

Devices eligible in Phase Ia are:

• Class III medical devices;
• Class IIb active medical devices intended to administer or remove medicinal products.

In Phase Ia the EMA gave priority to:

• Cardiovascular devices;
• Paediatric devices.

Manufacturers could submit only one application in Phase Ia. Following the closing date, the EMA selected five applications from Phase Ia.

Actions of the expert panels

The medical device expert panels, with the support of the relevant national competent authorities, assess these applications and take the following actions:

• Providing an opinion on the breakthrough status of the device;
• Providing advice in specific areas for designated breakthrough devices, where requested and in line with the MDCG guidance referenced on the EMA page.

The advice provided depends on the development stage of the device and may include opinions on:

• Preclinical evidence generation;
• Acceptability of the intended clinical development strategy;
• Acceptability of proposed clinical investigations;
• Acceptability of proposed post-market clinical follow-up activities.

Involvement of notified bodies

The MDCG guidance also allows notified bodies to submit specific questions to the expert panels. These questions may concern the clinical data required for a manufacturer's clinical evaluation of a designated breakthrough device as part of conformity assessment.

In Phase I, the notified body selected by the manufacturer participates in the request for advice for one of the five selected applications. That application must be the one with the most advanced device development among the five, i.e. at or near the conformity assessment stage.

How to apply to the pilot

Submit an expression of interest through the dedicated portal for the pilot phase on scientific advice from expert panels on certain high-risk medical devices, selecting "Advice within the scope of MDCG guidance 2025-9" as the application type.

Access to the application requires an EMA account. Applicants without an account should visit the EMA account management website and follow the steps under "Create an EMA account".

Pilot phases

Information on the phases of the breakthrough medical device pilot programme is subject to change.

Phase I (Ia and Ib)

Phase I of the pilot applies only to Class III devices and Class IIb active devices intended to administer or remove medicinal products.

Phase Ia is closed to applications. The EMA is reviewing a limited number of selected designation requests to test the first phase of the pilot. The review is expected to continue until 31 July 2026.

Manufacturers selected in Phase Ia whose device receives a positive opinion on breakthrough status may submit requests for advice from 1 September 2026. That date marks the start of Phase Ib, when the EMA will accept all applications within the scope of Phase I.

Applicants not selected in Phase Ia but considered eligible for Phase Ib do not need to resubmit an expression of interest. In Phase Ib they must submit a breakthrough status request briefing document using the template published on the EMA page. The deadline for submitting the breakthrough status request briefing document is 15 September 2026.

Phase II

Phase II is expected to start in the first quarter of 2027. In this phase the EMA will extend designation and advice requests to all categories of medical devices.

Phase III

Phase III is expected to start in the third quarter of 2027. In this phase the EMA will extend designation and advice requests to in vitro diagnostic medical devices (IVDs).

Pilot application templates

Application templates are available for download in Word format to help manufacturers prepare for the pilot procedures.

Manufacturers may submit these templates to the EMA only after their application has been confirmed as either selected for the pilot (Phase Ia) or within the scope of the pilot (other phases). These applications need not be attached at the expression of interest stage.

• Breakthrough status request: template for applicants to the breakthrough medical device pilot (English, 135.69 KB, DOCX). First published 24 April 2026; last updated 28 April 2026.
• Advice request: template for applicants to the breakthrough medical device pilot (English, 132.27 KB, DOCX). First published 24 April 2026; last updated 28 April 2026.

Information session

An information session was held to prepare for the launch of the breakthrough medical device pilot programme. Further information, including a recording of the event where available, is provided under "Breakthrough medical devices: information session (24 April 2026)".

Page update history

The page provides a log of the dates and summaries of changes to the webpage, excluding updates to linked documents and minor edits such as typographical corrections and broken-link fixes. Update tracking began in March 2026.

• 4 June: the "Phase I (Ia and Ib)" expandable panel under "Pilot phases" was updated to mark the closure of the Phase Ia submission window; the update also provides Phase Ib information, including requirements and applicant deadlines.
• 29 May 2026: the page introduction was updated to add information on the availability of parallel joint scientific advice for Class III implantable medical devices.
• 28 April 2026: sections "How the pilot works", "How to apply to the pilot" and "Pilot phases" were added, together with a "Related news" section; the PDF templates initially added for information purposes were replaced with Word templates that manufacturers can complete.
• 23 April 2026: sections on "Pilot application templates", "Guidance on breakthrough medical device designation" and the "Breakthrough medical device pilot information session" were added; the page introduction was also updated with the scope and launch date of the pilot.
• 2 March 2026: the page was first published. Content was migrated from another webpage as part of a broader content restructuring.

Related news

New pilot supports the development of breakthrough medical devices (28 April 2026).

AIMEILI regulatory interpretation and business impact

The pilot creates an accelerated route into the EU market for innovative device manufacturers, but eligibility, timing and evidence quality must be assessed before any application is prepared. The following four areas are most relevant for manufacturers outside the EU, including Chinese companies.

1. Regulatory pathway and device classification

The pilot currently applies only to Class III devices and to a defined subset of Class IIb active devices (those intended to administer or remove medicinal products), with priority for cardiovascular and paediatric devices. Manufacturers should first confirm whether their device falls within this scope. For innovative devices that do not yet hold CE marking, the pilot offers early access to expert panel views and may shorten the cycle for clinical evaluation and conformity assessment. However, places are limited, with only five applications selected in Phase Ia, so competition is intense; a complete technical file and a robust clinical data summary should be prepared well in advance.

2. Clinical evaluation and technical documentation

MDCG 2025-9, published in December 2025, is the core reference for any application. Manufacturers should prepare a clinical evaluation plan in line with that guidance, covering preclinical evidence, clinical development strategy, proposed clinical investigations and post-market clinical follow-up. The expert panels focus their advice on the acceptability of precisely these elements. Technical documentation must be consistent with the guidance, particularly regarding the sufficiency of clinical data and compliance with the MDR. Where documents are translated, terminology accuracy matters, because misunderstandings of key concepts can undermine an application.

3. Notified bodies and conformity assessment

The pilot allows notified bodies to put clinical data questions to the expert panels, which means manufacturers must work closely with their chosen notified body. Selecting a notified body that is willing and able to participate in the pilot is essential, and devices at a later development stage, at or near conformity assessment, may stand a better chance of selection. Early dialogue with the notified body on its role and obligations under the pilot is recommended.

4. Post-market surveillance and clinical follow-up

The expert panels assess not only pre-market data but also the acceptability of post-market clinical follow-up (PMCF) activities. Manufacturers should design a credible PMCF plan, including how real-world data will be collected and how long-term safety and performance will be monitored. This is especially important for breakthrough devices, which may reach the market faster on the basis of more limited data and therefore face more demanding post-market requirements. A well-structured post-market surveillance system aligned with the panel's advice is advisable.

Additional opportunities

For Class III implantable devices, manufacturers may also request parallel joint scientific advice (JSC) with HTA bodies, which helps align regulatory and health technology assessment expectations and reduces the complexity of multi-region registration. The EMA information session and the published Word templates should be used to prepare the briefing document early. Overall, the pilot offers a new model for international market entry, but a careful gap analysis and strategic planning should precede any submission.

Frequently asked questions

Can this article be used directly as a basis for a regulatory submission?

No. The content is intended for preliminary understanding and project assessment only. Any formal submission must be based on the latest requirements of the target regulatory authority, the confirmed classification of the device and the manufacturer's actual documentation.

What should a manufacturer do first after seeing this update?

Start with a documentation gap assessment to determine whether the update affects the registration pathway, technical file, labelling, quality management system or post-market maintenance obligations.

Does the pilot replace the standard MDR conformity assessment route?

No. The pilot provides non-binding expert panel advice on breakthrough status and on specific aspects of clinical evidence development; conformity assessment and CE marking remain with the notified body under Regulation (EU) 2017/745.

Source and applicability

Source: European Medicines Agency (EMA), original date 28 April 2026. This article is compiled from publicly available EMA information: https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/expert-panel-support-breakthrough-medical-devices-pilot-programme. Specific requirements remain subject to the latest official publications of the regulatory authority. This article supports preliminary understanding, documentation preparation and project planning and does not replace the formal requirements of the target regulatory authority, test conclusions or legal advice.