The European Commission’s Health and Food Safety newsletter announces a new pilot programme by the European Medicines Agency (EMA) to support “breakthrough” medical devices and IVDs, planned to start in the second quarter of 2026.
The idea is to create an early, structured channel where developers of highly innovative, high‑impact devices can receive enhanced regulatory support, similar in spirit to “breakthrough” or “priority” schemes known from medicines. The pilot is expected to focus on devices and diagnostics that address unmet medical needs or bring a step‑change in clinical practice, with the goal of shortening time to patient access while keeping MDR/IVDR safety and performance requirements fully in place.
For manufacturers, this will likely mean:
- a more intensive dialogue with regulators at an earlier development stage,
- closer interaction between EMA, MDCG and national competent authorities on device evaluation, and
- additional expectations on robustness of clinical and real‑world evidence to justify the “breakthrough” positioning.
Pure Clinical supports manufacturers in assessing eligibility for the EMA breakthrough pilot, shaping a compelling clinical and regulatory story, drafting and structuring the application, and preparing for interactions with authorities. Our team helps you articulate unmet medical need, position your device versus current standard of care, identify and close data gaps, and organise your internal stakeholders so that the pilot becomes a structured opportunity rather than an ad‑hoc fire drill.