EMA Launches Scientific Advice Pilot for Manufacturers of High-Risk Devices

The European Medicines Agency (EMA) is launching a pilot program to offer scientific advice to manufacturers of certain high-risk medical devices, to help streamline their path to market.

The pilot will allow manufacturers of Class III (high risk) and certain Class IIb (medium/high risk) active medical devices to consult with an expert panel to review their development strategy and clinical investigation proposals prior to clinical evaluation or investigation.

The pilot program will run through the first quarter of 2024 and will accept two batches of five applicants each — a total of 10 devices. The agency plans to announce the first round of pilot participants in April and the second round in September. There is no participation fee.

Devices intended to benefit small groups of patients, to address unmet medical need or novel devices with potential major clinical or health impact will be prioritized for the pilot program.

The pilot will begin accepting letters of interest from manufacturers by the end of February.