All about Eudamed, the European Database for Medical Devices

Eudamed is the IT system developed by the European Commission, implementing Regulation (EU) 2017/745 on medical devices. Its objective is to provide an up-to-date picture of the lifecycle of devices made available in the European Union (EU). It therefore constitutes a unique database to improve transparency and coordination of information.

The system will be multipurpose. It will function as a registration system, a collaborative system, a notification system, and a dissemination system, and will be based on six interconnected modules and a public website.

What the MDR Says about Eudamed

The Regulation (EU) 2017/745 dedicates Articles 33 and 34 to Eudamed, detailing its objectives and structure.

In particular, the database should allow:

• the public to be adequately informed about devices placed on the market, the corresponding certificates issued by notified bodies, relevant economic operators, and clinical investigations;
• unique identification of devices in the internal market and facilitate their traceability;
• manufacturers to comply with information obligations;
• the competent authorities of the Member States and the Commission to carry out their tasks relating to the regulation on an informed basis and to enhance their mutual cooperation.

What Information is Stored in Eudamed

Where the MDR text refers to “electronic system” or more explicitly to “Eudamed”, it refers to a specific module of the six that will make up the database:

• 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

Each of these modules must be populated and periodically updated by each of the entities involved in the medical device field.

Some of the information that will be required within these modules is already the subject of national databases, developed under the previous directive. Eudamed will enter a very heterogeneous landscape: although the MDR pushes for compatibility between these systems, it is not certain that Eudamed will guarantee automatic import and export of data.

To date, only the first of the six modules is actually active and accessible.

Indeed, since December 1, 2020, manufacturers, authorized representatives, system and procedure pack producers, and importers can register in the Actor registration module.

This initial registration allows for the collection of data from all involved actors.

Following the verification of the entered data, Eudamed will generate a unique registration number (Single Registration Number, SRN), with the aim of uniquely identifying a company for its role in the medical device sector.

Who Can Access Eudamed

In order to achieve the objectives on which the entire database is based, all information collected and processed by Eudamed must be accessible to notified bodies, economic operators, sponsors, and, most importantly, to the public.

For this reason, the European Commission ensures that the public parts of Eudamed will be presented in an easy-to-use and consult format.

Already today, in the public section of Eudamed, it is possible to search for actors who have met the registration requirement discussed above.

European Medical Device Nomenclature (EMDN) in Eudamed

In 2005, the Italian Ministry of Health established that the National Classification of Devices (CND) would be the official classification and nomenclature system for medical devices. About 15,000 manufacturers worldwide have used the CND to register their medical devices in the Italian database.

The development of the CND was based on three key principles: participatory approach, involving all stakeholders in the development, qualified validation of proposals, and most importantly, free public availability.

This has allowed the Italian National Classification of Devices to become a comprehensive and detailed system, capable of managing the heterogeneity of the sector. And that’s why the European Medical Device Coordination Group (MDCG) decided, at the meeting on February 14, 2019, to adopt the CND as the official nomenclature for the European Eudamed database.

The system, derived from the CND, will constitute a single European classification system for medical devices called EMDN.

Useful Resources on the Eudamed Database

Among the tasks of the Medical Device Coordination Group (MDCG), established by the European Commission, is to provide a series of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR).

These are guidelines that present a common vision of how the MDR should be applied in practice for effective and harmonized implementation. Among the topics covered is Eudamed.

Guidance is provided on managing the transition before the full publication of the system, the methods for registering economic operators, registration timelines, and other useful information.

What is the MDR (Medical Device Regulation), in Brief

For the sake of completeness, it’s worth remembering that the Medical Device Regulation (MDR) defines the rules for the certification of medical devices in Europe. It came into force on May 26, 2017, and will repeal Directive 93/42/EEC starting from May 26, 2021.

The objective of the MDR is to create a new regulatory framework recognized internationally and increase the clinical safety of products. Moreover, a regulation, unlike directives, does not need to be transposed into national law, limiting divergent interpretations between different EU states.

Preparing for the New Provisions

Manufacturers of CE-marked medical devices under 93/42/EEC will need to adapt their products and quality system in compliance with the transitional provisions, excluding vigilance, surveillance, and registration requirements – which apply immediately.
Manufacturers of new devices, on the other hand, must manage the CE marking process in accordance with the new regulation starting from May 26, 2021.

In addition to manufacturers, unlike Directive 93/42/EEC, the regulation defines obligations also applicable to distributors and importers. The two figures now have direct responsibilities in ensuring the placing on the market of compliant products.

Given the stringent requirements, the landscape of related and applicable documents, and the direct impact on the ability to continue or start a business in the sector, interested organizations must make strategic decisions, focus on training, and adapt to the MDR with the support of competent consulting firms.

You can contact us to explain your organization’s situation and obtain for free a clear picture of the applicable requirements and specific adaptation times.