EU COMBINE Pilot Expands to Cover Investigational Devices and ATMP Combination Studies

Quick take: Phase 2 of the European Commission’s COMBINE pilot launched in late June, widening the program to include investigational medical devices and combined studies involving Advanced Therapy Medicinal Products (ATMPs). Rolling applications open in September, for a one-year window.

What changed: Phase 1 of COMBINE covered in vitro diagnostics (IVDs) only. Phase 2 adds:

• Clinical investigations of medical devices requiring authorization
• Combined studies involving Advanced Therapy Medicinal Products (ATMPs), most commonly cell and gene therapies
• Options for single or separate sponsors

Why it matters: Previously, a clinical trial combining a medicinal product with a physically separate, non-CE-marked device required a medicinal product clinical trial application plus individual device clinical trial applications in every country where the trial would run. COMBINE offers a more streamlined path: a single assessment process instead of a stack of parallel filings. Individual member states still review applications and may raise questions on the drug or device, so this isn’t a free pass. It does remove a significant amount of redundant, country-by-country filing.

Who should pay attention: Sponsors planning a combination product or ATMP-device clinical trial with EU sites, particularly where the device isn’t CE marked, have a real opportunity to simplify their regulatory pathway during this pilot window.

Timing: Rolling applications open in September 2026 and remain open for one year.

Suttons Creek is tracking this pilot closely as it develops. If you’re evaluating a combination product or ATMP-device program with EU trial sites, [find us] to talk through whether your program fits.

Source: European Commission COMBINE Phase 2 notice

AUTHOR

Jonathan Amaya-Hodges, Vice President, Technical Operations, Suttons Creek – Jonathan has over 16 years of multidisciplinary experience in regulated medical products (drugs, biologics, medical devices, and combination products) at multiple global companies. He has practical experience in Development/Engineering, Quality Assurance, and Regulatory Affairs for various types of combination products with a focus on drug delivery. Additional background includes digital health (including smart packaging/connected devices and software as a medical device, or SaMD) and in vitro diagnostics, along with clinical development (bridging) and lifecycle management for combination products. Jonathan engages with the global combination product community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics.