The European Medicines Agency (EMA) has introduced a new platform enabling manufacturers of specific high-risk medical devices to seek scientific guidance. This initiative, which began as a pilot program in early 2023, now offers permanent support to companies developing Class III and certain Class IIb devices involved in administering or removing medications. The EMA aims to facilitate quicker access to innovative technologies through expert consultations. Initially offering free advice to a limited number of firms, the agency is now expanding this service to all eligible manufacturers, fostering advancements in clinical development strategies and investigational proposals.
The establishment of this scientific advice procedure stems from a comprehensive evaluation of a pilot project initiated by the EMA. During this trial phase, the agency aimed to provide complimentary scientific counsel to ten companies. Recognizing the value of this initiative, the EMA decided to make it a permanent feature. Manufacturers can now submit inquiries regarding clinical investigations that have not yet commenced, focusing on devices classified as Class III and certain Class IIb active devices intended for medication administration or removal.
To engage with this process, companies must first express interest using a dedicated form. Following submission, they will participate in an exploratory meeting, where they present detailed information about their device and intended clinical strategy. This interaction culminates in the expert panel delivering written recommendations to each applicant. According to the guidance document, manufacturers are required to give due consideration to the views expressed by the expert panel, potentially necessitating additional actions based on the received advice.
In its initial pilot phase, the EMA prioritized devices addressing unmet medical needs and novel technologies with significant potential health impacts. Moving forward, these criteria will be applied only if the volume of submissions exceeds the capacity of the expert panels. Additionally, the agency launched a separate pilot program for orphan devices targeting rare diseases, encouraging manufacturers in this niche to seek advice through this specialized channel until the end of 2025.
This new portal marks a significant step towards enhancing the regulatory pathway for high-risk medical devices. By providing manufacturers with expert guidance, the EMA aims to streamline the development and approval processes, ultimately accelerating patient access to innovative and effective medical solutions. The ongoing commitment to supporting technological advancements in healthcare underscores the agency's dedication to improving public health outcomes.