EMA Launches Advice Portal to Speed Up High-Risk Medical Device Approvals

The European Medicines Agency (EMA) has officially launched a scientific advice portal for manufacturers of high-risk medical devices, including class III devices and class IIb active devices used for drug administration or removal. Through this portal, companies can consult expert panels on their clinical development strategies before initiating investigations, ensuring their approaches align with regulatory expectations. The EMA initially tested this initiative through a pilot project and has now made it a permanent offering, providing free expert consultations to facilitate faster market access for innovative medical technologies.

The new process involves submitting an interest form, attending an exploratory meeting, and receiving structured feedback from an expert panel before obtaining formal written advice. While manufacturers are not required to follow the guidance, they must give it "due consideration" and may need to take additional actions to comply with regulations. The EMA will prioritize requests based on factors like unmet medical needs and potential clinical impact, while manufacturers of orphan devices are encouraged to seek guidance through a separate rare disease pilot program running until the end of 2025.