In collaboration with the European Commission, the European Medicines Agency (EMA) has launched (10 February 2025) a regular procedure for providing scientific advice to manufacturers of certain high-risk medical devices. This initiative aims to enhance innovation, improve patient safety, and support regulatory compliance for devices that require rigorous clinical validation before market approval.
This new advisory mechanism follows a successful pilot programme started in February 2023 and is expected to streamline clinical development while ensuring that medical devices meet the highest safety and performance standards.
1. What Are High-Risk Medical Devices?
A high-risk medical device is any medical product that:
Interacts with the human body in a way that could pose significant health risks.
Is intended for critical medical procedures, such as implants, life-supporting devices, or drug administration systems.
It falls under Class III or specific Class IIb categories and requires strict regulatory oversight.
Device Classifications Covered Under the New EMA Procedure:
🔹 Class III Medical Devices: These include implantable medical devices, such as pacemakers, artificial heart valves, and deep-brain stimulators.
🔹 Class IIb Active Medical Devices: These devices administer or remove medicinal products from the body, such as insulin pumps or dialysis machines.
2. What Is the EMA Scientific Advice Procedure?
The scientific advice procedure allows manufacturers of high-risk medical devices to receive early-stage regulatory guidance on their clinical development plans.
This procedure
Ensures that clinical investigations meet European regulatory standards.
Helps manufacturers design better clinical trials, avoiding unnecessary delays.
Reduces regulatory uncertainties before submission for CE marking under the Medical Device Regulation (MDR) (EU 2017/745).
3. Key Features of the EMA Scientific Advice Procedure
A) Who Can Apply?
🔹 Developers of orphan medical devices (devices intended for rare diseases).
B) How to Apply?
🔹 Applications are submitted via the EMA’s online portal.
🔹 The process allows manufacturers to engage with expert panels during different stages of clinical development.
C) Role of Expert Panels
🔹 The EMA expert panels provide:
Scientific guidance on study design.
Technical and clinical insights to improve device performance.
Regulatory recommendations to align with MDR standards.
D) Fee Structure
🔹 Currently, there are no fees for requesting scientific advice from EMA.
4. EMA’s Pilot Programme on Orphan Medical Devices
The EMA has also introduced a pilot programme for orphan medical devices, which are developed for treating rare conditions. Manufacturers developing such devices can apply for specialised support through this initiative.
5. Expected Impact on Medical Device Innovation
✅ Faster Access to Market
Reduces clinical trial errors, leading to faster approvals.
Helps manufacturers design efficient and compliant studies.
✅ Better Patient Safety
Ensures robust clinical evaluation before market entry.
Enhances transparency in risk-benefit assessment.
✅ Stronger Regulatory Compliance
Aligns with EU MDR (2017/745) requirements.
Provides clearer guidance to device manufacturers.
The EMA’s scientific advice procedure marks a significant step forward in regulating high-risk medical devices. By offering early-stage guidance, the EMA ensures that new medical technologies are both safe and effective before reaching patients.
🔗 For full details, visit:EMA High-Risk Medical Devices Guidance
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