ARTICLE SUMMARY:
The EU has launched its pilot breakthrough program. Excerpted from Pathways’ Picks May 8: Notified Body Rules, EU Breakthroughs, China Exemptions, and More.
The first phase of the EU’s breakthrough medical device pilot program launched April 28. Initially, there are openings for devices from five manufacturers to be considered for designation as breakthrough devices that can benefit from streamlined premarket expectations, extra input from expert panels, and prioritization from notified bodies. The pilot, administered by the European Medicines Agency, will prioritize cardiovascular and pediatric devices in Phase Ia. All high-risk device categories will be eligible to participate in Phase Ib starting later in the year, and the pilot scope will expand to lower-risk devices and IVDs over the course of 2027. The European Commission spelled out the principles of breakthrough devices in a December 2025 guidance, drawing key themes from FDA’s Breakthrough Device Program. Ultimately, the EU plans to embed the concepts into law via the legislative reforms currently being debated by lawmakers.