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3 January 2023

European Database on Medical Devices

The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746). EUDAMED is IT system developed by European Commission that allows patients and stakeholders to access a large quantity of data and useful information; the goal is to improve overall transparency in the sector as well as to improve coordination of information regarding medical devices available on the EU market.


EUDAMED is structured of six modules related to: actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance, and market surveillance.


Currently only three of six modules are available. The economic operators can register themselves on a voluntary basis until EUDAMED is fully functional.


EUDAMED actor registration module (Article 30)

The first module, actor registration module, is available from December 2020, thus allowing manufacturers, authorized representatives, importers, and procedure packs producers to identify themselves with the form of an actor registration request. After the assessment of data by relevant competent authority, they issue the SRN (single registration number). A SRN is the Single Registration Number that is released through EUDAMED by the competent authority in accordance with Article 31 MDR and 28 IVDR. The SRN guarantees an EU-wide unique identification for economic operators. Once the SRN has been obtained, the operator will gain access to the second module for the medical device’s registration.


Unique device identification (UDI) and devices registration module (Article 28 & 29 (4))

The second module, unique device identification (UDI) and device registration module, is a feature available since October 2021. UDI allows easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market for now on a voluntary basis. Therefore, additional national requirements on registrations cannot be excluded.


Basic UDI-DI is a unique identifier (code + characteristics) that refers to group of products from the same manufacturer. Basic UDI-DI should not be confused with the UDI-DI identifier (unique device identifier). Its main key is to connect devices with same intended purpose, risk class and essential design and manufacturing characteristics. The basic-UDI appears in the technical documentation of the device; in the EU Declarations of Conformity and in the EU Certificates of Conformity.


UDI-DI identifier is a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and allows unambiguous identification of specific devices on the market.



Notified bodies and certificates module (Article57)

At the beginning of October 2021, the third module, notified Bodies (NB) & Certificates module, is available. This module allows NB to register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn, or refused and other restrictions imposed on these certificates. Such information is accessible to the public. This module also allows to look up which NBs have already been recognized and registered on NANDO (Notified Bodies database).


Certificates are the official written confirmations from NB that a product may be placed on the market. After a conformity assessment, they may be issued for up to five years. The paper Certificate version is identified by a unique number which is the “NB number + Certificate number (+ possibly ‘Revision number’)”. The EUDAMED Certificate data version is identified by the “Certificate paper version unique identifier” and the “EUDAMED version number”.


Clinical investigations module (Article 73)

A patient-centric approach to healthcare is vital. Clinical trials are required to determine the comparative efficacy of two or more therapies. The EUDAMED system is to serve as the main electronic system for clinical investigations.


Market surveillance module (Article 100)

Market surveillance in the context of medical devices, and more specifically EUDAMED, is the enforcement of the harmonized legislation on medical devices.


Vigilance and post-market surveillance module (Article 92)

The overall concept behind the MDR is that of ensuring safe products on the EU market. Even though all precautions and measures are taken, certain mistakes might still happen. Through the EUDAMED system, a centralized location for the handling of corrective actions will be in place.


The remaining three modules will be available gradually. The European Commission has published a new schedule on its website, where the full functionality of EUDAMED is presented:



It is advisable for all stakeholders, but especially for manufacturers, to work proactively on the content for the individual EUDAMED modules. Although the transition periods are linked to the activation of the modules, intensive discussion and preparation should take place earlier in order to not to fall behind later.