Accelerating patient access to breakthrough medical technologies in Europe

After years of calls from patients, healthcare professionals and innovators, the EU has taken a meaningful step towards getting innovative, life-saving medical technologies to patients faster. On 28 April 2026, the European Commission, the Medical Device Coordination Group (MDCG) and the European Medicines Agency (EMA) launched a breakthrough pilot – a structured trial to test how highly innovative medical devices and in vitro diagnostics can move more efficiently through EU approval processes. Starting with cardiovascular technologies, the pilot aims to improve coordination between regulators, expert panels, Notified Bodies and manufacturers, and to lay the groundwork for a permanent EU breakthrough pathway for technologies addressing serious or life-threatening conditions. 

 The breakthrough pilot: what it is and why it matters 

The pilot provides an early framework for closer, more structured cooperation between regulators, expert panels, Notified Bodies and manufacturers. Its broader objective is the creation of a permanent EU breakthrough pathway, a dedicated regulatory route for medical devices and in vitro diagnostics that offer a genuinely novel diagnostic or therapeutic option and address unmet needs in serious or life-threatening conditions. 

Such a pathway has long been a priority for the medical technology community. Existing regulatory processes are not always well-suited to highly innovative technologies, and the EU has lacked the targeted tools that other major jurisdictions (notably the United States, through the FDA Breakthrough Device Designation) have used to accelerate patient access to transformative innovations. 

MedTech Europe has actively advocated for this pathway and welcomes the complementary initiatives now taking shape: the MDCG guidance on breakthrough technologies, the inclusion of a formal breakthrough pathway in the European Commission’s proposed MDR and IVDR revision, and the launch of the pilot itself. Together, these measures signal a growing recognition at the EU level that targeted regulatory tools are essential for supporting innovation and closing the access gap. 

 What it means for patients  

A functioning breakthrough pathway is ultimately about patients, and the gap between what is possible and what is accessible in Europe today is real. Technologies that introduce a high degree of novelty and deliver significant clinical benefits for life-threatening or irreversibly debilitating conditions too often reach European patients later than elsewhere, or not at all. 

A dedicated pathway should change that by enabling faster, more predictable regulatory processes for the technologies where speed genuinely matters. Closing the innovation and access gap is not a secondary objective: it is the purpose of the exercise. 

 What it means for business 

A dedicated breakthrough pathway sends a clear signal to innovators and investors: Europe is open to transformative medical technology and committed to supporting its development. 

For manufacturers, a breakthrough designation by expert panels should enable earlier dialogue with expert panels and Notified Bodies, access to enhanced scientific advice, and prioritisation of conformity assessment — leading to shorter, more predictable timelines to market. 

Reduced uncertainty and faster market access are decisive factors in investment decisions. A credible breakthrough pathway strengthens the EU’s position as a first-launch destination and supports the SME-driven innovation ecosystem that underpins European competitiveness.

The broader context: simplification is equally critical 

The pilot and the MDCG guidance are welcome short-term measures, but they operate within a broader regulatory environment that still requires urgent attention. 

The ongoing MDR/IVDR revision, with its focus on simplification, is equally important. So too is the Annex VII Implementing Act, which sets out more predictable, transparent and proportionate timelines and costs for conformity assessment by Notified Bodies. Together, these instruments are central to restoring confidence in the EU regulatory system and ensuring that a breakthrough pathway does not become an island of efficiency in an otherwise difficult environment. 

Looking ahead 

The pilot is designed to test the provisions of the MDCG guidance in practice and to identify what works well and where adjustments are needed. This learning phase is important: the EU is building a framework tailored to its own regulatory architecture, and the pilot provides the structured opportunity to do that rigorously. 

Once the initial cardiovascular-focused phase is completed, the scope will be broadened to other medical devices and, in time, IVDs. As that process unfolds, it will be essential to define clear timelines for the full breakthrough process, enabling objective assessment of performance and building the confidence of manufacturers and investors alike. 

MedTech Europe welcomes the launch of the breakthrough pilot and the commitment it represents from the European Commission, the MDCG and the EMA. We look forward to active collaboration throughout the pilot phase and beyond, to ensure that the permanent breakthrough pathway delivers real and measurable benefits for patients across Europe.