EUDAMED is the European Database on Medical Devices. It is similar to other public government databases, such as the US FDA’s database, which contains all registered Establishments, 510(k)s and pre-market approvals, device listings, adverse events/recalls, clinical investigation data, and more.

EUDAMED is referenced throughout the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR). EUDAMED is designed to house information such as:

• • registration of economic operators (specifically: manufacturers, authorized representatives, importers);
  • registration of devices;
  • CE marking certificates;
  • clinical investigations;
  • vigilance and market surveillance.

The information is public and it is obligatory that all responsible parties comply and populate the database with the appropriate information.

Registration in EUDAMED is separate from marketing approval/conformity assessment. Companies must first obtain marketing authorization for the device, i.e., CE Marking. Then they can register that device into EUDAMED.

EUDAMED aims to consolidate medical device and IVD registration information into a central databank. It can seem complicated, when in fact the steps for EUDAMED compliance are straight-forward.

The basic steps to register in EUDAMED are:

1.  Manufacturer creates a EUDAMED account here: EUDAMED restricted site. This is a different site than the: EUDAMED Public Database

2. Manufacturer submits its Actor Registration request. Information needed includes: Actor Type (e.g., Manufacturer); Actor Name & Address; Authorized Representative, if applicable; Manufacturer’s Person Responsible for Regulatory Compliance; Upload several forms..

3. Authorized Representative reviews & accepts or rejects request. Once accepted, manufacturer’s Actor registration is routed to to National Competent Authority for final review.

4. The Competent Authority completes final approval & issues an SRN (Single Registration Number) to the manufacturer. The Authorized Representative is not involved with this process.

5. Manufacturer can now register its products in the EUDAMED UDI/Devices Module. 

How is EUDAMED structured?

EUDAMED will be comprised of six different modules*.

1. 1. Actor registration
   2. UDI/Devices registration
   3. Notified Bodies and Certificates
   4. Clinical investigations and performance studies
   5. Vigilance and post-market surveillance
   6. Market surveillance

Modules are simply different sections of EUDAMED. For example, to search for various medical devices, go to the EUDAMED public website and then click on the “Devices” box. You will then be sent to a page where you can begin searching.

*The modules in italics are already available for use on a voluntary basis. The remaining modules are pending release.

Are there fees to register in EUDAMED?

EUDAMED is completely free of charge. This is unlike many other government systems, which charge fees for new registration and/or maintenance of the registration listing, such as the US FDA, UK MHRA, Singapore HSA, Australian TGA, among others.

When do I need to start using EUDAMED?

Currently EUDAMED is voluntary, but industry is strongly encouraged to get started now.

EUDAMED was originally scheduled to be fully functional by May 26, 2020. However, EUDAMED  has been postponed and now has a Q2 2024 ‘full functionality’ date. This is per the EU Commission’s latest published EUDAMED timeline.

The following steps are required before EUDAMED becomes mandatory:

• • EUDAMED to pass successful independent audit (all six modules)
  • Be published into the Official Journal of the EU (OJEU), which will then be followed by a six month transition period.
  • This means, if the Q2 2024 fully functional date is met, then EUDAMED is mandatory for the four modules listed below by Q4 2024
    • Actor Registration
    • Vigilance
    • Clinical Investigation & Performance Studies
    • Market Surveillance
  • The is a further 18-month compliance/transition period for the UDI/Device registration & Notified Body & Certificates modules. This means, if the Q2 2024 fully functional date is met, then EUDAMED is mandatory for these final two modules in Q2 2026.

In the meantime, industry should follow the registration requirements per the Directives (MDD, AIMDD, IVDD).

While the formal compliance date seems distant and use is voluntary, many already expect companies to start registering in EUDAMED. For example, your importer may insist you complete your EUDAMED Actor registration, so that they can then link you in their Actor importer registration.

Another example is that the Irish Competent Authority (HPRA) asks manufacturers to register in EUDAMED to fulfil the MDR/IVDR registration requirement, even though use is voluntary. Specifically, they state that:

“The HPRA recognises the voluntary registration module of Eudamed in the absence of a fully functional Eudamed. Once Eudamed is fully functional, this will become the mandatory registration system. The HPRA is therefore requesting that MDR manufacturers, authorised representatives and system and procedure pack producers … to voluntarily register their details on Eudamed to meet the obligations set out in the Regulation.”