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Medtech Insight Register Eudamed Database

Manufacturers and other economic operators will be able to register, on a voluntary basis, in a new module of the Eudamed medical device database, updated to reflect the requirements of the Medical Device Regulation, as of 1 December.

While it is open for use at that point, device industry actors will need support in understanding it; the European Commission has just published a series of much-awaited guidance (see table below).

The MDR requires all medical device actors, including manufacturers, to register in the updated Eudamed database from 26 May 2021, regardless of whether they have devices CE marked under the directives or the regulations that will replace them.

With the delay in setting up the database, mandatory registration will not start yet. Instead, voluntary registration begins on 1 December and preparation for this among industry is being actively encouraged.

"The module going live as of 1 December is the actor registration module, which is for registering EU economic operators that require registration. This will allow the SRN (single registration number) to be assigned to each economic operator, which is a precursor to device registration, but device registration won’t be available until May 2021 when the UDI/Device Registration module is scheduled to go live," Kat Crowder, senior manager, global regulatory affairs explained to Medtech Insight.

She added that legacy devices that are CE marked under the directives only need to be registered in the updated Eudamed database 18 months after the date of application, or 26 Nov 2022. In addition, their registration in Eudamed will be mandatory earlier if there is a serious incident that occurs or a field safety corrective action to apply on them. That requires their registration as soon as possible and at least before a follow up or final vigilance report is submitted, Crowder noted.

Avoiding Duplication

While registration at EU level is initially voluntary, the commission has asked EU competent authorities to promote the process and to try to avoid double registration occurring on a national level.

At present, manufacturers and authorized representatives of CE marked medical devices need to register on a national basis in the EU country where they have an office or place of business, which is why there is a risk of duplication.

Belgium is among those countries that has committed to encouraging its industry and to avoiding double registration, Valerie Nys, program manager at the Belgian federal agency for medicines and health products (FAHMP), told the recent TOPRA 2020 Symposium earlier this month.

What Support Will Be Available

The European Commission is helping prepare all actors – manufacturers, authorized representatives, system and procedure pack producers and importers  ̶  by populating its webpage on Eudamed with a series of documents, forms, infographics and a video which makes the process clear. (Distributors are not registered in Eudamed).

The commission had already published its Medical Device Coordination Group Position Paper, MDCG 2020-15, on the use of the Eudamed actor registration module and of the Single Registration Number (SRN) in the member states in mid-April.

Access to the Eudamed database and to the new Eudamed webpage will be active from 1 December.

There is a list of additional tools now available. Most are very short and the video seems particularly helpful, but the technical documentation diagrams are challenging to follow:

 

EUDAMED Help Tools

Basic Description Of Help Tool

Info Type

Actor roles and SRN

Which economic operators can register and how, and the general validation process to receive a single registration number (SRN)

Infographic

Actor registration request process

How non-EU actors must submit actor registration requests, the role of the authorized representative and what happens when corrections may be needed, as well as the validation process

Infographic

Demo actor registration module

Five-minute demonstration of the registration process

Video

Declaration on information security responsibilities

This must be signed and included in the registration process

Form

Mandate summary document

One-page form that non-EU manufacturers should provide in their actor registration request

Form

Users access requests

How local actor administrators (LAA) can request access to Eudamed, the role of the local user administrators (LUA) and the hierarchy of those with access to Eudamed according to the different types of actors.

Infographic

Technical documentation

 

Actor module business practice

 

 

Document containing a flow chart explaining the process for a competent authority of how to register and the process for economic operators to register, including non-EU manufacturers.

Technical details and diagrams

Actor module business rules

 

This "Business Rules" document lists the constraints, limitations and business rules that drive the implementation of registration module of Eudamed and answers many questions and addresses some basic requirements and factors.

List

AIM - business process

 

How to create, update and manage a Eudamed account, including the process for a first LAA request from a notified body, and authentication and access management.

Technical details and diagrams

AIM - business rules

 

 

As with the actor modules business rules, this document also contains answers to many basic questions and explains basic factors, especially in relation to the LAA

List

The LAA (local actor administrator) registers the company etc. It is responsible for managing mandates, requesting an access point and accessing to machine to machine transfers, for example.The LUA (local user administrator), meanwhile, manages the users and their roles and can permit users to add and confirm submissions. These specific users can then add data to the various modules (such as UDI).

 

While the remaining modules of the database are still under construction, the European Commission has agreed to a piecemeal introduction which makes EU registration possible.

Editor's note: This story was updated on 22 October 2020 to reflect registration is for actors only (not devices) and to explain the timeline for legacy products.

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