EMA Launches Early Scientific Advice Program for High-Risk Medical Devices

The European Medicines Agency (EMA) has launched its Early Scientific Advice (ESA) program, offering manufacturers of high-risk medical devices tailored guidance on clinical development and regulatory strategies. The program is designed to help these manufacturers navigate the regulatory process more smoothly, ensuring that their devices meet the rigorous standards set by the European Union for market approval.

On 10 February 2025, EMA announced that manufacturers of certain high-risk medical devices can now submit requests for advice from EMA’s expert panels. The program is available to Class III implantable devices, Class IIb active devices, and Class D in vitro diagnostic devices—all of which are considered high-risk categories due to their complexity and potential impact on patient health. Manufacturers seeking advice on clinical investigation designs, risk assessments, and regulatory pathways for these devices can now receive valuable feedback before moving forward with their product development.

The ESA program is offered at no cost to manufacturers, with no fees currently associated with the scientific advice requests. This makes the program particularly attractive for manufacturers looking for expert insights on optimizing clinical trials, refining data collection strategies, and ensuring alignment with EU regulations. EMA’s expert panels will assess the clinical evaluation and performance reports submitted by manufacturers, helping to ensure that their devices meet EU regulatory standards before submitting them for approval.

The launch of this program is a significant step towards improving regulatory support for high-risk medical devices. By providing early guidance, the ESA program helps manufacturers reduce uncertainties and streamline their paths to market, ensuring safer and more effective devices for the European healthcare system. Further details on procedure for requesting advice from Expert Panels on clinical investigations and/or clinical development strategies for high-risk medical devices can be found on EMA’s website.

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At Gladiolus Quality & Regulatory Services, we specialize in helping manufacturers navigate the complexities of EU regulations and CE marking approvals. Our expert team can assist with early scientific advice requests, preparing your submissions for EMA consultations, and ensuring that your high-risk medical devices meet all regulatory requirements. Whether you're seeking guidance on clinical trials, risk assessments, or aligning with EU standards, we are here to support you every step of the way. Reach out today to ensure your device meets the regulatory expectations and successfully enters the European market.