One important change would be a mechanism to certify innovative, orphan and breakthrough devices under the existing legal framework. A new MDCG Working Group on special pathways could be tasked with this by reviewing and issuing binding opinions on pre-certification reports by notified bodies. The working group consists of representatives of member states and utilizes existing expertise at the notified bodies. Proper support is essential for its success.

Additionally, we need a shift from document-centric to data-centric regulatory processes to foster a more agile and responsive regulatory environment. This would include integration of data from various sources (e.g., pre-market clinical investigations, post-market surveillance) to provide a comprehensive view of a device’s performance, leading to more informed regulatory decisions, as well as automated data collection and analysis to reduce the administrative burden for manufacturers and notified bodies and lead to faster and more efficient certification and surveillance processes.

Medtech 2025: EU Regulatory Outlook Brings Challenges

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