EUDAMED (European Database on Medical Devices) is an IT system created by the European Commission under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). Its primary function is to improve transparency and strengthen the oversight of medical devices that are placed on the European market. The system is not yet fully operational, but is expected to be up and running towards the end of this year. 

I am curious how much information this system will store and how it will be used by regulatory bodies, whether it be for audits/inspections or market surveillance. Please share if you know any more information on this. 

EUDAMED is a big step towards transparency with medical devices. Even after a year from the last post in this forum, EUDAMED is still not fully operational or mandatory. It was originally set to become mandatory in May 2020, but it is still in progress because of the complexity of the project and how difficult it is to communicate with all the stakeholders effectively. Right now, there are 3 voluntary active modules available, which are Actor Registration, Unique Device Identification & Device Registration, and Notified Bodies and Certificates. Actor Registration is where authorized people must register before placing devices on the market. Unique Device Identification & Device Registration is where each device gets a unique number so it can be tracked. Notified Bodies & Certificates increase information of certificates of the device and whether it conforms to standards. The in-progress modules include Clinical Investigations & Performance Studies, Vigilance & Post-Market Surveillance, and Market Surveillance. Clinical Investigations & Performance Studies are the registration of outcomes of clinical studies regarding the device. Vigilance & Post-Market Surveillance is to report negative events and the actions taken for correction. Market Surveillance is regulatory inspections and enforcement by the EU. The first mandatory deadline is expected in early 2026, but with three entire modules still in progress, nearing the end of 2025, I think the project will be pushed back again. However, using the available modules now would be very helpful to stay in compliance and could help companies keep up with the times. 

EUDAMED will be a single source of truth to support regulators, as they can conduct audits, investigations, and market surveillance with the entire database. For healthcare and patients, it increases transparency with public information, making them feel safer and up-to-date on the latest affairs in the medical devices realm. Manufacturers can use the database to stay in compliance and also develop new devices. With the graph you have posted, the increase in total processed registrations is linear, which is a very good sign. 

However, with the volume of data in the database already, smaller companies can have a harder time keeping up with increasingly complex requirements. There is also a confidentiality issue: how much data should be publicly shared without affecting the trade secrets of different companies? With the mandatory use of EUDAMED, this becomes an increasing issue. Right now, everyone is voluntarily submitting their data, but with strict requirements, could the medical devices game change? This is a double-edged sword, as safety and transparency can increase with the cost of regulatory burden. With MDR/IVDR, some companies would not work with the compliance costs and timelines, causing them to leave the market. This could happen with mandatory EUDAMED. However, if this works out, the U.S. can adopt a similar approach. Do you think EUDAMED will be a regulatory tool or a resource for manufacturers to showcase themselves and find opportunities?