On 28 April 2026, the European Medicines Agency (EMA) announced the launch of a pilot programme to support the development of so-called “breakthrough” medical devices: highly innovative technologies with the potential to address unmet medical needs. This marks a major regulatory turning point for Europe, one that draws direct inspiration from the model the FDA put in place a decade ago.
What is a “breakthrough” device?
Under this programme, breakthrough designation may be granted to medical devices that demonstrate significant potential to treat serious conditions with no adequate therapeutic solution, or that offer a substantial clinical advantage over existing technologies. The assessment takes into account the degree of innovation, potential clinical impact, and comparison with currently available alternatives.
“The pilot marks an important step in strengthening Europe’s innovation-friendly regulatory environment for medical technologies, with the goal of ensuring patients can access safe and effective breakthrough innovations as quickly as possible.”
EMA, April 2026
How the EMA pilot works
The programme will run in three phases. Phase one is open to class III (high-risk) medical devices and active class IIb devices intended to administer or remove medicines from the body. Subsequent phases will progressively extend to other device types, including in vitro diagnostics (IVDs).
Manufacturers whose device receives the designation benefit from priority access to scientific opinions from EMA’s medical device expert panels, enhanced regulatory support throughout development, and a clearer pathway to CE certification. The initiative builds on a guidance document published in December 2025 by the European Commission’s Medical Device Coordination Group (MDCG), and is part of the broader revision of the MDR/IVDR framework.
The American model: a pioneer since 2015
To understand what is at stake, it helps to look across the Atlantic. The FDA launched its Breakthrough Devices Program in 2015-2016, formally established through the 21st Century Cures Act, with one clear objective: to speed up the development, assessment, and market authorisation of potentially lifesaving medical devices.
1,041
Designations granted by the FDA (Sept. 2024)
128
Devices that actually reached the US market
~75 days
Estimated average review time saved
In practice, the FDA programme has delivered measurable benefits for manufacturers: direct and rapid access to regulatory experts, the ability to design flexible clinical trials, and priority review of market authorisation applications. These advantages made the programme highly attractive, with over 1,000 designations granted in under a decade.
The picture is not without nuance, however. Critical analyses, including an investigation by STAT News, have highlighted that while the programme has significantly benefited device developers, its actual value for patients remains difficult to measure. Out of more than 1,000 designations, only around 128 devices have reached the market. A breakthrough designation makes regulatory review easier; it does not resolve the challenges of clinical development, funding, or the robustness of evidence.
EMA vs FDA: two approaches, one shared goal
Comparing the two programmes reveals both meaningful similarities and important structural differences.
EMA Breakthrough pilot (Pilot 2026)
- Anchored in MDR/IVDR revision (art. 52a)
- Phase 1: class III and active class IIb devices
- Priority access to EMA expert panel opinions
- Enhanced support for manufacturers
- Scope still limited (IVDs in later phases)
- Real-world outcomes yet to be confirmed
FDA Breakthrough Devices Program (Active since 2015)
- Voluntary, open to all device types
- Direct access to FDA experts, flexible trials
- Applies to 510(k), De Novo and PMA pathways
- Few devices actually on market (~12%)
- Patient benefit still debated
One key structural difference sets the two systems apart. In Europe, medical device certification goes through notified bodies (accredited private entities) rather than a central authority like the FDA. The EMA therefore plays a scientific support role through its expert panels, rather than acting as a direct approval authority. This decentralized model makes implementing a breakthrough programme more complex than in the United States, which explains the pragmatic choice of a phased pilot approach.
Expected benefits for the European ecosystem
Beyond reducing time to market, the programme targets several strategic objectives. It aligns with the ambitions of the EU Biotech Act, which seeks to strengthen European competitiveness in cutting-edge health technologies. By offering manufacturers a clearer pathway and an identified scientific contact point, EMA hopes to retain in Europe developers who might otherwise have prioritised the American market first.
For patients, there is a faster access to potentially transformative technologies, from smart implantable devices to advanced molecular diagnostics and therapeutic brain-machine interfaces, without compromising the safety and performance standards that underpin the MDR framework.