The European Union Medical Device Regulation (EU MDR) aims to create a transparent and innovative medical device landscape. A cornerstone of this effort is the European Database on Medical Devices (Eudamed).
As a developer with experience in medical devices, I have been exploring how AI could streamline EU MDR compliance. This post examines Eudamed’s current state and its potential to achieve the MDR’s goals. In future posts, I will elaborate on specific AI use cases.
EU MDR and Eudamed Ambitions
The EU MDR, enacted in 2017, aims to protect patient safety while fostering innovation.
The Eudamed database is a key instrument:
“One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical devices (Eudamed) that should integrate different electronic systems to collate and process information regarding devices on the market and the relevant economic operators, certain aspects of conformity assessment, notified, bodies, certificates, clinical investigations, vigilance and market surveillance. The objectives of the database are to enhance overall transparency, including through better access to information for the public and healthcare professionals, to avoid multiple reporting requirements, to enhance coordination between Member States and to streamline and facilitate the flow of information between economic operators, notified bodies or sponsors and Member States as well as between Member States among themselves and with the Commission.” Link source
Assessing the benefits of this substantial investment by the EU and the medical industry is essential. How does Eudamed currently measure up, especially in comparison to its FDA counterpart?
Investigating Transparency:
To gauge EUDAMED’s efficacy, I examined the listed medical devices of Denmark’s five largest public manufacturers (Ambu, Coloplast, Demant, GN Store Nord, Novo Nordisk). My goal was to compare the insights from EUDAMED to those readily available on company websites.
Unfortunately, EUDAMED currently falls short of providing the intended transparency. Most of the medical devices of those significant Danish companies are not in the database. The public and healthcare professionals then need to find other sources. In contrast, the FDA database is complete and offers more robust functionality, such as a Unique Device Identifier (UDI) lookup and access to premarket reviews and adverse event reports.
Conclusion and Call to Action
While EUDAMED’s progress lags behind its aspirations and the FDA’s offerings, this is understandable given its relative infancy. However, this highlights an urgent need to accelerate the generation and integration of high-quality data within EUDAMED.
Advanced analytics and AI hold vast potential to speed up this process, enhance data quality, and reduce compliance costs for the industry. We can help the EU MDR realize its full potential by harnessing these technologies.
I’m passionate about developing AI solutions in this domain. If you share this interest, let’s connect!
