EMA Breakthrough Devices Pilot Program 2026

The European Medicines Agency (EMA) will launch a pilot program in the second quarter of 2026 to support breakthrough medical devices and in vitro diagnostics (IVDs). The EMA breakthrough devices pilot program 2026 is designed to test a regulatory pathway that accelerates patient access to highly innovative technologies, defined by a high grade of novelty and positive clinical impact, while maintaining the EU’s strict standards for safety and performance.

Through this pilot, manufacturers of designated breakthrough devices will receive enhanced regulatory support and priority scientific advice from medical device expert panels administered by EMA.

Key Objectives of the Pilot Program

The EMA pilot aims to:

• Accelerate access to highly innovative medical technologies  

• Support devices demonstrating novelty and positive clinical impact  

• Maintain EU requirements for safety and performance  

• Improve structured early dialogue between regulators and manufacturers  

This initiative reflects a broader EU strategy to enable faster adoption of transformative technologies without reducing regulatory rigor.

Regulatory Framework and Legal Basis

The pilot program builds on the framework established under:

• Guidance from the Medical Device Coordination Group (MDCG 2025-9)  

• The European Commission proposal 2025/0404 (COD) published in December 2025  

This proposal introduces adaptive certification procedures for breakthrough technologies, including:

• MDR Article 52a  

• IVDR Article 48a  

These provisions allow manufacturers to seek early scientific advice from expert panels, improving regulatory predictability during development.

Expert Panel Involvement and Designation Process

To qualify as a breakthrough technology under the pilot program, manufacturers must request an opinion from the relevant EMA expert panel.

The assessment is based on whether the device demonstrates:

• A high level of technological novelty  

• A positive clinical impact  

• Addressing an unmet or significant clinical need  

Only devices meeting these criteria may be designated as breakthrough technologies and access the pilot support pathway.

Regulatory Support Offered Under the Pilot

Manufacturers accepted into the pilot program will benefit from:

• Priority scientific advice from EMA expert panels  

• Enhanced regulatory interaction throughout development  

• Structured guidance on classification and evidence expectations  

• Early alignment with MDR and IVDR requirements  

This support is intended to reduce uncertainty and improve regulatory efficiency for innovative technologies.

Compliance Expectations and Manufacturer Actions

Manufacturers should prepare by:

1. Evaluating whether the device meets breakthrough criteria (novelty + clinical impact)  

2. Preparing clinical evidence demonstrating performance and benefit  

3. Engaging early with regulatory planning under MDR/IVDR frameworks  

4. Submitting a formal request for expert panel opinion  

The EMA will publish detailed guidance documents and application templates ahead of the pilot launch to support consistent submissions.

Impact on EU Medical Device Regulation

The EMA breakthrough devices pilot program 2026 is expected to:

• Strengthen early regulatory engagement mechanisms  

• Improve predictability in MDR/IVDR pathways  

• Accelerate access to high-impact medical technologies  

• Support innovation while preserving strict EU safety standards  

It represents a structured step toward more adaptive regulatory models for breakthrough healthcare innovation.

How This Fits into EU Innovation Strategy

This pilot supports the EU’s broader regulatory modernization agenda by enabling:

• Faster translation of innovation into clinical use  

• Early scientific validation of breakthrough technologies  

• Stronger collaboration between manufacturers and regulators  

It reinforces the EU’s position as a globally stringent but innovation-aware regulatory environment.

Internal Sources

• EU Medical Device Classification & Regulation (MDR/IVDR)

External Sources

• European Medicines Agency official pilot program page  

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