Eudamed is a database developed to enable the implementation of European Regulations 2017/745 (MDR) and 2017/746 (IVDR) with the aim of providing an up-to-date picture of the life cycle of medical devices made available in the European Union. It constitutes a unique database to improve transparency and coordination of information.

In its final form, it will consist of 6 modules and a publicly accessible section.

The six modules, each with a specific function but interconnected, are dedicated to:

Registration of economic operators (manufacturers, authorized representatives, importers);
UDI and device registration;
Notified bodies and certificates;
Clinical investigations and performance studies;
Vigilance and post-market surveillance;
Market surveillance.

Who Must Register in Eudamed

Registration in Eudamed is required for various types of actors (natural or legal persons) who will use its services and populate its database.
The roles that actors can assume in Eudamed and therefore must proceed with registration, are: Commission (EC), Competent Authorities (CA), Designated Authorities (DA), Notified Bodies (NB), Manufacturers (MF), Authorized Representatives (AR), System and Procedure Pack Producers (PR), Importers (IM).

Among these actors, the last four (MF, AR, PR, IM) are called economic operators, while the others (EC, CA, DA, NB) are called control bodies.

If an actor assumes multiple roles among those provided, they must perform a registration for each role held.
For each registration, Eudamed will assign a unique Actor ID to the actor who submitted the request for a certain role. The Actor ID is called SRN (Single Registration Number) if the request is made for the role of Manufacturer, Authorized Representative, or Importer.

There are some special cases depending on which registration in Eudamed may or may not be necessary.

Manufacturers of ‘legacy devices’ and/or MDR devices: registration is required and must be completed within the timeframes indicated in the following paragraph.

Manufacturers of only ‘old devices’: in this case, registration is required only if the Manufacturer or Authorized Representative (in case of a non-EU Manufacturer) is still active. In this case, actors will be assigned an Eudamed ID and not an SRN. The registration will serve to allow possible reporting of serious incidents or FSCAs through the IT platform.
If the Manufacturer or Authorized Representative is no longer active, registration is not required, and any communications of incidents or FSCAs will be made outside of Eudamed.

Manufacturers of only custom-made devices: registration in Eudamed is not required if the manufacturer produces exclusively custom-made devices, considering that this type of device will not need to be registered in Eudamed.
However, there are two cases where a manufacturer of only custom devices must register in Eudamed with the MF role:

In case a class III implantable custom device is manufactured, the Manufacturer must proceed with registration before the Notified Body uploads the related certificate of conformity to Eudamed;
In case of the need to report a serious incident, FSCA, or Trend Report for custom devices of any risk class.

System and Procedure Pack Producers (SPPP): Manufacturers of only SPPs are required to register in Eudamed within 6 months from the publication in the Official Journal of the notice of full functionality of the IT platform in order to fulfill the UDI coding registration obligations provided for in Article 29(2) of the MDR.
In this case, the actor will be assigned an Eudamed ID and not an SRN.

Importers who assume responsibilities provided for Manufacturers according to Article 16 MDR/IVDR: importers who fall under the cases provided for in Article 16(1) are required to proceed with registration also as Manufacturers.
Importers who, instead, fall under the cases provided for in Article 16(2) will not have to proceed with registration as Manufacturers.
It remains valid that, in both cases, the actor is expected to register as an Importer.

Eudamed Timeline: Mandatory or Voluntary Registration?

The registration of actors in Eudamed will be mandatory starting from the date corresponding to six months from the date of publication of the notice of full functionality of the IT platform published in the Official Journal.
Despite this, it is already possible (and strongly recommended, given the technical times for obtaining the Actor ID) to proceed with the registration request for the roles held.

According to Article 31 of Regulation (EU) 2017/745, Manufacturers, Authorized Representatives, and Importers have the obligation to register in Eudamed before placing a medical device (other than a custom-made medical device) on the market. These actors have 24 months from the date of publication in the Official Journal of the notice of full functionality of Eudamed to comply with this obligation.

How to Register in Eudamed

The registration process for the IT platform is the same for all economic operators (except for some required data) excluding non-EU Manufacturers for whom it will be necessary to identify an Authorized Representative already registered in Eudamed.

Roles within Eudamed

Before going into detail on how to register in Eudamed, it is appropriate to clarify the possible roles that can be assumed within it and their hierarchical relationships.
Premising that each user can have multiple accounts and access to the IT platform can be made from only one account at a time, let’s see what profiles a user can assume depending on the role of the actor with which they have logged in:

For each profile, there is a hierarchy as illustrated in the following table:

In particular, we can see how, for all economic operators, the profile with the broadest privileges is the LAA (Local Actor Administrator) who has the privileges to manage all data of the actor within Eudamed and the access requests made by other users of the same actor.
At a lower level, we have the LUA (Local User Administrator) who, unlike the LAA, cannot manage the actor’s data, and finally, we have the lowest level, Viewer, who can only view the information entered without modifying it in any way.

It is good practice for each actor to plan to register at least two LAAs in order to have redundancy and prevent the eventuality of not having a person who can access Eudamed with these privileges at any time.

To give a practical example and reorganize the ideas among all these acronyms, let’s take the example of Acme Corporation, which manufactures class I medical devices and, at the same time, also acts as an importer of medical devices manufactured by third parties.

Acme Corporation will need to proceed with two requests for SRN codes in Eudamed: one for the role of Manufacturer and one for the role of Importer.

A person within Acme Corporation will proceed with the creation of an EU Login Account from which it will be possible to start the processes of requesting the two SRN codes through the actor registration request.

Once the SRN codes are obtained, Acme Corporation, in the roles of Manufacturer or Importer, can proceed to add other accounts with different profiles (LAA, LUA, Linker (only for the Importer role) and Viewer) by requesting new accesses.

1. Access the Eudamed homepage and click on “Create your EU Login Account”.

2. Enter the required information to create the account.
The account being created will have the role of LAA.

3. The system will create the account and automatically send a link to the email address provided during registration to generate credentials. Once the credentials are generated, it will be possible to access your Home, from which to proceed with the registration of an economic operator or the request for access to an existing economic operator.

How to Register an Economic Operator: Actor Registration

STEP 1 – As an initial step, indicate the role for which the request is being made (possible roles for economic operators are: Manufacturer, Authorized Representative, Importer, System/Procedure Pack Producer), the country where the organization is based, and the name of the organization (as reported in the Chamber of Commerce registration).

STEP 2 – Information useful for identifying the organization will be requested, such as any secondary names or abbreviations, VAT number, and EORI number (if available). Once all the information useful for uniquely identifying the organization has been provided, you can move on to the next screen.

STEP 3 – Indicate the organization’s contact details as reported in the Chamber of Commerce registration.
Not all data are mandatory: post office box, latitude, and longitude can be omitted if not significant.

STEP 4 – The following are required:

Contact details for Competent Authorities, i.e., the contact of the first person who acts as an interface with the CAs in case of need. There are no specific requirements or roles to be filled by the person indicated;
Public contact details: this data will be publicly visible through consultation of the Eudamed database.

STEP 5 – This section is present only for those roles (Manufacturer, Authorized Representative) that require the presence of the Person Responsible for Regulatory Compliance (PRRC).
It is possible to indicate multiple people who hold this role and, if necessary, specify the responsibilities of each.
If the PRRC is external to the organization (an eventuality contemplated only for micro and small enterprises), it is necessary to indicate the contact details of this figure. Otherwise, by selecting the item “Same Address as the Actor organization address“, the data provided in STEP 4 will be used.

STEP 6 – At this point, indicate whether the person making the application, i.e., the LAA, works for the organization for which the registration request is being made (in this case select “No”) or if they are an external collaborator (select “Yes”).

In the same section, we are asked to upload a declaration (Declaration on Information Security Responsibilities, obtainable here) through which it is declared that the economic operator accepts the right to use the European medical device database in compliance with what is reported in the document itself and that it undertakes to respect the responsibilities and obligations established therein. It also confirms being authorized to provide the information requested in the document and that the information provided is correct.
The information entered in paragraph III of this document must be the same as that provided for the creation of the LAA account.

STEP 7 – The Competent Authority is automatically selected based on the country chosen in STEP 1. In this section, there is a free text field that should be used to communicate additional information to the Competent Authority.
For example, where an external PRRC to the organization has been identified, in this section the declaration on the size of the organization should be reported (which we remind must be classifiable as micro/small according to Recommendation 2003/361/EC of the Commission).
Another case where it is necessary to use this field is if the request for registration in Eudamed is dictated by the need to report a serious incident or an FSCA.

At the end of the procedure, the request will be evaluated by the Competent Authority which will confirm the registration by issuing the SRN or reject it by contacting the LAA via email and specifying, more or less completely, the reasons for the rejection.

The Three most Common Errors During Registration

The experience gained through the registration of multiple economic operators in Eudamed allows us to identify three common errors during registration for which there are no specific indications, but which can lead the Competent Authority to reject the issuance of the SRN.

A generic email address is used for LAA registration: the Competent Authority does not accept addresses like info@; it is necessary to use email addresses traceable to a person.
In case of an external PRRC, the declaration of being a micro/small enterprise is not provided.
The entered data does not match the Chamber of Commerce registration.

How to Add Users in Eudamed: New Access Request

To add users (with different privilege levels), you will need to proceed with a new access request.

Once an EU Login Account has been created for the person who wants to be added among the users of an already registered actor, from the homepage, by selecting “New Access Request,” it will be possible to provide the SRN code or the references of the actor of interest and send them an access request.

Proceeding with the request, you will indicate your references and with which privilege level you wish to be included among the users of the chosen actor.

The LAA or LUA of the actor will need to proceed with accepting the access request to finalize the procedure and confirm (or deny) the requested privileges.

What is the SRN Code and where to Use It

As mentioned earlier, every actor who registers in Eudamed receives a unique identifier called Eudamed ID. When the Eudamed ID refers to a Manufacturer, an Authorized Representative, or an Importer, it is called SRN or Single Registration Number.

The SRN is used to allow unique identification of the actor: