Medical Device Registration in Eudamed: the Guide

Where Medical Devices are Registered

The registration of medical devices in the Eudamed database is one of the new duties assigned to medical device Manufacturers as required by Article 29 of Regulation (EU) 2017/745.

To date, the registration of medical devices in Eudamed is not yet mandatory, while it remains necessary to register products in individual national databases such as that of the Ministry of Health.

In the following paragraphs, we will see the timelines for fulfilling the obligations set by the new Regulation and the operational methods to comply with them.

When to Register Medical Devices in Eudamed

The regulation presents an inconsistency in defining a single timeline for the registration of medical devices in Eudamed, so much so that the publication of the MDCG 2019-4 was necessary to clarify this aspect.

Considering that at the date of publication of the Regulation, the IT platform was not fully functional, the registration obligations for medical devices in Eudamed according to the methods provided for in both part A and part B of Annex VI of Regulation (EU) 2017/745 will become mandatory 24 months after the date of publication in the Official Journal of the notice of full functionality of the platform (Article 34(3)).

In the absence of further specifications, Manufacturers remain obligated to register their devices in individual national databases.

How to Register a Medical Device in Eudamed

To be able to register your devices in Eudamed, it will be necessary to:

• Have completed the actor registration in Eudamed and consequently be in possession of your SRN code;
• Have defined, for each device and for each relevant packaging level, a complete UDI coding (Basic UDI-DI, UDI-DI, UDI-PI);
• Have added a second Account to your organization on Eudamed, as better described in the next paragraph.

Creation of a Second EU Login Account

Once your organization is registered in Eudamed, it will have a single user account with the LAA role (the role is automatically assigned to the person who first makes the request to register the organization).

By default, this user does not have the privileges to propose and approve the registration of the company’s codes.

For this reason, it will be necessary to create a second user account that can request (or assign) these privileges to the first one.

Let’s now see in detail how to do this:

1. Create a new EU Login Account
2. Make a new access request

3. Identify which organization you intend to make the access request to. You can identify the organization through its SRN code or by specifying its Role, Nationality, and Name.

4. Choose which privileges you want to request from the organization. The privileges identified at this stage relate both to the type of user you are asking to become for the actor (LAA, LUA, or Viewer) and to the role you want to play in registering UDI codes according to this logic:

• Proposer: can proceed with the compilation of all data related to the products to be registered, but requires the authorization of the Confirmer to proceed with the actual registration;
• Confirmer: like the Proposer, can proceed with entering product data and can directly proceed with their registration. Approves or rejects data entered by Proposers.

It is also possible to define an expiration date (End Date) for the requested privileges if you want to limit them in time.

N.B. If the user account being created will be responsible for proceeding with the registration of medical devices, then it should request Confirmer privileges. If instead you want to give these privileges to the LAA, the user account being created should have at least LUA privileges so that it can update the LAA’s privileges and make it a Confirmer.

Once the request is submitted, the LAA (and any LUAs) of the specified organization can decide whether to accept or reject the entry of the new user.

Registration of a Medical Device: UDI and Eudamed

We now have everything in order to proceed with the registration of the first device.

Accessing Eudamed with a user account that has Proposer or Confirmer privileges, the Tasks section submenu will be available as shown in the following image:

The registration of a new device in Eudamed always involves the registration of a Basic UDI-DI code and a UDI-DI code.

The relationship between the two types of codes is one-to-many, meaning it’s possible to link multiple UDI-DIs to the same Basic UDI-DI (but not vice versa). When registering a new product, there are two paths:

• Register a new Basic UDI-DI, in this case, it is always required to register at least one UDI-DI linked to that Basic UDI-DI;
• Register a UDI-DI with an already registered Basic UDI-DI. In this case, you can take advantage of the one-to-many relationship and link the new registration with the data related to the already entered Basic UDI-DI.

Considering the first case, selecting the “Register a new Basic UDI-DI” option will start the registration process, which consists of 6 forms through which all product information will be requested.

Once all relevant fields have been filled, if you only have Proposer privileges, you can save as draft the registration request waiting for a Confirmer user to approve it. If you have Confirmer privileges, you will proceed directly with registering the device in the database.

If instead you want to add another UDI-DI code to an already registered Basic UDI-DI, you can do so by accessing the “Manage your Basic UDI-DI/EUDAMED DIs” section. The registration steps are identical to those reported above (except for those related to the Basic UDI-DI code, considering that this information has already been entered) and to be repeated for each individual medical device to be registered.

Legacy Devices: should They be Registered in Eudamed?

As anticipated in the previous paragraphs, Eudamed offers the possibility to register Legacy devices as well.

For Legacy devices, the definition of a UDI coding is not required. However, it is possible to proceed with their registration in Eudamed with methods very similar to those seen for devices compliant with the Regulation. The only differences will be:

• To start the registration of a Legacy device, you will need to use the menu item “Register a Legacy Device”;
• Since the assignment of a Basic UDI-DI code is not required, the IT system will directly assign a unique identifying key to the device. This key is called Eudamed DI. It’s important to remember that, unlike the Basic UDI-DI, the Eudamed DI is unique for each device and therefore the relationship between Eudamed DI and Eudamed ID is always 1:1;
• Since the assignment of a UDI-DI code is not mandatory, the system allows either to assign a UDI-DI code to the device using the same methods used for non-Legacy devices or the system itself will generate a unique identifying key for the device. This key is called Eudamed ID;
• It will be necessary to provide data related to the product’s MDD certificate (Notified Body notification number, revision, and expiration date of the certificate).

In case a medical device is registered in Eudamed as Legacy and subsequently certified according to MDR, it is necessary to proceed with a second registration providing a new UDI-DI and Basic UDI-DI code. It will then be possible to link the new registration to that of the Legacy device only if the only difference between the two is the change in conformity (from Directive to Regulation).