New EMA Procedure: Scientific Advice for High-Risk Medical Devices
The European Medicines Agency (EMA) has introduced a significant new opportunity for manufacturers of Class III and Class IIb active medical devices. This initiative, developed in collaboration with the European Commission, provides scientific support to companies to optimize their clinical strategies and facilitate market access.
What’s Changing for Manufacturers?
- A Dedicated Portal: Companies can now request advice online, with monthly submission deadlines.
- Expert Support: Manufacturers will be able to consult EMA panels at different stages of clinical development.
- A Structured Process: Following a pilot project launched in February 2023, which received positive feedback, the service is now a permanent part of EMA’s offerings.
Benefits for Medical Device Manufacturers
- Stronger Clinical Strategy: Targeted advice to reduce regulatory risks.
- Faster Market Access: Fewer bureaucratic hurdles and better planning for clinical investigations.
- Greater Regulatory Clarity: Clear guidance on MDR compliance requirements.
An Opportunity for Orphan Devices
For devices intended for the treatment of rare diseases, EMA recommends submitting requests through the dedicated pilot program, active until the end of 2025.
How to Submit a Request?
Companies can access the service through a dedicated portal with detailed instructions and a monthly submission calendar. For more information, visit the official EMA website.
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