EUDAMED is the European database for medical devices. However, it is not only used to manage medical devices.
The Medical Device Regulation (MDR) relies on EUDAMED and determines which requirements must be stored in this database.
These regulations affect the work of manufacturers and also the work of authorities and notified bodies.
EUDAMED stems from the EU Commission Decision 2010/227/EU in which the EU frames the aim of EUDAMED:
"The aim of the European databank for medical devices is to strengthen market surveillance by providing competent authorities with fast access to information on manufacturers and authorized representatives, devices and certificates and to vigilance data, to share information on clinical investigation data, as well as to contribute to a uniform application of those Directives, in particular in relation to registration requirements."
EUDAMED is thus intended to help that
The Medical Device Regulation MDR obliges manufacturers to store data about themselves and their devices in the EUDAMED:
Article 32 requires adding a summary of safety and performance to EUDAMED for Class III devices and implants. The database should also be (partially) accessible to the public.
EUDAMED stores much more data than just the UDIs (see Fig. 1).
The EU comission decision mentioned above also determines which data EUDAMED must store. These include:
a) Actor (manufacturer/authorized representative)
e) Clinical Investigation
The Commission Decision uses the term "databank" and not "database".
There are many more data fields. Most modules now have their own data dictionaries and business rules. These describe if the data fields are mandatory or optional.
Just as the devices in the EUDAMED must be clearly identified via the UDI-DI, the manufacturers must also be identifiable. This also applies to other economic operators, including importers and EU representatives, except distributors.
This unique identification is the "Single Registration Number" (SRN). For this purpose, economic operators must register in EUDAMED. The registration data is then validated by the authority responsible for the economic operator. After successful validation, EUDAMED generates a unique SRN and assigns it to the corresponding economic operator. The sponsors of clinical investigations also require an SRN.
The corresponding registration module has been operational since December 2020. After initial difficulties, registration and release by the German state authorities is also possible.
Manufacturers are obliged to keep the data in EUDAMED up to date. For this purpose, they can appoint a "Local User Administrator" (LUA). The LUA in turn manages the authorizations for the persons designated by the manufacturer.
It is possible for a manufacturer to authorize its importer or its EU representative as a LUA.
How manufacturers can appoint a LUA is described in the Economic Operator Guide on the EUDAMED website. Chapter 2.2.2 states
Anyone with an EU Login account can request access to a registered actor, but only a user with a Local User Administrator (LUA) or a Local Actor Administrator (LAA) profile can validate these requests. The first person who registers an actor in EUDAMED automatically receives a LAA profile. This includes the LUA rights for managing new user access requests.
This means that the first person who submits the initial registration exercise request for the manufacturer in EUDAMED as an economic operator becomes LAA and can then validate further requests from LUA profiles.
However, a company can receive several SRNs. This is the case if the company has several roles, for example, as a manufacturer of one device and as an importer of another device from another company. The role of the EU representative also leads to a separate SRN. Conversely, an EU representative representing several companies would only have one SRN, as the representative remains in the same role.
Clinical investigations are a special case because the devices do not yet have a CE mark. Therefore, they do not have to be or cannot yet be registered.
Because the EU Commission explicitly wants to record these clinical investigations, there is a separate module. The sponsors - usually the manufacturers - must register in this module and also require an SRN. An exception applies if the inspections are conducted outside Europe. Conversely, manufacturers must register studies with CE-marked devices if they are "invasive or burdensome" (see Article 74). These inspections are also known as PMCF inspections. (PMCF stands for Post-Market Clinical Follow-up).
Manufacturers may authorize their CROs (Clinical Research Organizations) to maintain the data in EUDAMED.
1. the possibility of online input (for humans),
2. an interface that allows the upload of XML files and
3. a machine-to-machine interface.
Even the protocol (https) is determined by the EU. However, the XML interfaces are only partially specified (see below).
This module is used to register the devices. The attributes that manufacturers or authorized representatives must enter are described above and in the manuals referenced there.
The EMDN uses the UDI module to classify devices.
Other actors that must register are
Another module is used to manage the certificates that the notified bodies have to set.
There are two vigilance modules: one for the " competent authorities" and one in which the economic operators (i.e., not just the manufacturers) provide information on reportable events.
There is also a market surveillance module for the competent authorities.
In the CI/PS module, the plans and outputs of "Clinical Investigations" (CI) and "Performance Studies" (PS) are published in the case of IVDs.
To date (as of May 2023), only the modules
have been activated.
In February 2021, the MDCG published the MDCG guideline entitled "Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional." This guidance document Guideline MDCG 2021-1 lists in tabular form which alternative solutions are possible until EUDAMED is fully functional.
Please note, however, that each Member State regulates how to deal with the obligations of the MDR (which are related to the EUDAMED) as long as the EUDAMED is not yet fully functional. In Germany, for example, this is set out in the notice named: "Bekanntmachung nach § 97 Absatz 1 Satz 2 und Absatz 2 des Medizinprodukterecht-Durchführungsgesetzes zur Regelung des Übergangszeitraums bis zur vollen Funktionsfähigkeit der Europäischen Datenbank für Medizinprodukte nach Artikel 33 der Verordnung (EU) 2017/745 vom 26. Mai 2021".
In June 2022, the EU published a timetable for releasing the remaining modules on its website. The original plan was to announce in the EU Official Journal in Q2 2024 that EUDAMED was fully functional. As of August 2023, this schedule has been removed from the EUDAMED website, and there are no longer any precise details for releasing the missing Vigilance, Clinical Investigation/Performance Studies, and Market Surveillance modules.
The MDCG describes how to proceed with IVD devices up to this point in time in the guidance document MDCG 2022-12 entitled "Guidance on harmonized administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)".
A similar document was published on the EU website at the beginning of 2022. In this document, publication in the Official Journal was scheduled for the second quarter of 2023.
On April 11, 2022, the EU made new documents on technical documentation available in the EUDAMED UDI/Devices module.
So far, the EUDAMED project has gone better from a technical point of view than many prophets of doom predicted. Nevertheless, the changeover would have been a Herculean task for everyone involved. But that is all a thing of the past. This time, the policy decision to launch EUDAMED with full functionality has made all schedules obsolete.
Admittedly, there were challenges, especially for manufacturers with many devices, as the "mass upload" had not been specified, implemented, or even tested. Managing hundreds or thousands of devices via a web interface is hardly possible.
At present, there is not much you can do as a manufacturer as far as EUDAMED is concerned. However, you should not delay your preparations for the UDI. There is a lot of work waiting!
Read more about the Unique Device Identification UDI here.