What is the EUDAMED database?
The range of medical devices and implants is particularly extensive: worldwide there are more than 4.5 million different types and more than 6,000 pieces are added every week. With the – soon to be launched? -EUDAMED database requires the European Union numerous additional registrations. A good thing, but what exactly is the EUDAMED database? And when will it go live? We are happy to explain.
EUDAMED stands for “European Database on Medical Devices” and is a central database managed by the European Commission. The aim is to centralize all information on medical devices (from pacemakers, hip, knee and breast prostheses to surgical instruments, screws and plasters) in the European Union. And thus guarantee traceability and transparency.
EUDAMED is based on a decision of the European Commission (2010/227/EU). The reason is several incidents, for example the PIP scandal (faulty breast implants from a French manufacturer), which clearly showed that the centralized management of data makes sense and can even save lives.
What is stored in the EUDAMED?
EUDAMED is part of the European medical device legislation, in particular the Medical Devices Regulation (MDR) and the In-vitro Diagnostic Medical Devices Regulation (IVDR), which are in force in the EU. The EUDAMED database will comprise a total of 6 interconnected modules.
1. Module ACT – Registration
With this module, manufacturers, importers or representatives of medical devices can register and be clearly identified later.
2. Module UDI – Identification
The UDI module will contain all specific information per medical device and will have the same functions as the comparable database of the American Health Authority (FDA) GUDID.
3. Module CRF – Certificate
Every medical device distributed in Europe will have a valid approval certificate in the future confirming that the product meets all legal requirements. These certificates will be managed in the CRF module in the future.
4. Module CIPS – Clinical Research
Under the new Medical Devices Regulation (MDR), manufacturers of medical devices are required to carry out a clinical assessment for all their medical devices, regardless of risk class, including post-market clinical follow-up (PMCF). The results of these studies will be made publicly available through this module.
5. Module VGL – Vigilance
Any serious medical device incident must be documented in the VGL module of the EUDAMED database. The number and type of incidents must be stated in the technical documentation. Security corrective actions must also be reported.
6. Module MSU – Market Surveillance
Finally, the results of market surveillance are fed back in the MSU module. The competent authorities are the ones who carry out the market surveillance and publish the reports.
When will the EUDAMED database go live?
The launch of EUDAMED was originally planned for 2020. However, a first postponement (to 2022), a second postponement (to 2023) and even a third postponement (to Q2 2024) soon followed. For the time being, this last date is still being adhered to. We are already curious.
As a first step, EUDAMED must pass an independent audit and be considered fully functional. Once this is done, it will be published in the Official Journal of the European Union (OJEU). After publication in the OJEU, a transitional period of six months starts.
New planning for EUDAMED
At the end of the six-month transition period, the following EUDAMED modules will become mandatory:
• Module ACT - registration
• Module VGL - vigilance
• Module CIPS - clinical research
• Module MSU - Market Surveillance
If the target of Q2 2024 is met, EUDAMED will therefore be mandatory for the above four modules in Q4 2024. The remaining EUDAMED modules (module UDI – identification and module CRF – certificate) still have a transition period of 18 months (Q2 2026) .
Meanwhile, 3 of the 6 EUDAMED modules are currently available for voluntary use: registration, identification and certificate.
Source: https://health.ec.europa.eu/system/files/2023-01/md_eudamed_timeline_en.pdf
Carefree choosing EcoMet
As a hospital, do you still trace your medical devices and implants on paper or through self-applied stickers? Or do you, as a supplier, have a large stock of medical devices or implants on consignment at hospitals? Then choose the future-proof solution eCoMET®.
eCoMET® is a 100% digital solution that allows you to register and trace implants and medical devices at a glance, including expiration date and lot number. Moreover, this is linked to the uniform GTIN or UDI codes with which you automatically register these products in the European database EUDAMED. In short, nothing but benefits.
