Introduction of European medical device database eudamed

Objective: To investigate the mechanism of the disease

Eudamed registration is a European database, which is an IT system recommended by the European Commission for medical devices and in vitro diagnostic equipment to meet some requirements mentioned in EU MDR 2017 / 745 and EU ivdr 2017 / 746 regulations.

The EU Department of agriculture will enhance transparency among the public and healthcare professionals and coordinate information on medical devices and IVD on the EU market.

Eudamed includes the following electronic systems:

(a) The electronic system for device registration described in section 29 (4); and;

(b) UDI database referred to in Article 28;

(c) The electronic registration system for economic operators described in Article 30;

(d) The certification authority and certificate electronic system referred to in Article 57;

(e) The electronic system for clinical research described in Article 73;

(f) The vigilance and post market regulatory electronic system referred to in Article 92;

(g) The electronic system of market supervision referred to in Article 100.

As can be seen from the above subsystems, after the MDR is officially implemented, the following information must be registered in eudamed; Information of registered economic operators (manufacturers, importers, etc.), device UDI information, CE certificate, clinical research information, warning and post marketing regulatory information, market regulatory information, etc

Country code + role code + 9-digit code.

The role code includes:

Manufacturer -- MF

Authorized representative -- ar

Package assembly plant -- pr

Importer -- Im

SRN should be applied by corresponding economic operators and allocated after confirmation by corresponding competent authorities.

Euamed registration steps:

Step 1 - Basic udi-di and UDI

Basic udi-di and UDI are obtained from "issuing entities" designated by the European Commission (such as IFA GmbH, GS1 aisbl, HIBCC, iccbba).

Step 2 - registration of manufacturers, EU representatives and importers

Economic operators should register in the "role registration module", and need to input the information of economic operators and equipment related information.

After verifying the information entered, the competent authority will receive a "single registration number" from the electronic system, which will be sent to the economic operator. The manufacturer shall use this SRN to apply to the notification authority for conformity assessment.

Step 3 - device registration

In the UDI / device registration module, add the basic udi-di that has been received from the publishing entity, and then add additional information about the device and manufacturer.

Core data elements, such as the number of information per package, the name and address of the manufacturer, SRN, member state information, etc.

For low-risk MD and IVD (followed by the registration process), the EU declaration of compliance needs to be prepared according to the relevant regulations launched by the market. For high-risk equipment, the compliance assessment needs to inform the organization to participate.

After the approval of the CE mark, the manufacturer shall prepare the declaration of conformity for the market.

Q&A

1. A company applies for a SRN, right?

It should be noted that if the same company undertakes the roles of several different economic operators, it should apply for corresponding SRN respectively. For example, if the Belgian enterprise is both a manufacturer and an importer, there are two applications for SRN:

Be-mf-000000002 (as manufacturer)

Be-im - 000000003 (as importer)

2. Can non EU manufacturers submit their applications directly?

Non EU manufacturers are not allowed to submit SRN applications directly, but need to be verified by EU authorized representatives, who will submit the applications to the competent authorities of Member States for approval. Of course, EU authorized representatives need to obtain their own SRN in advance.