There are more than 500,000 types of medical devices in the European Union (EU) market. Their importance for the healthcare sector as a whole and for each individual patient cannot be underestimated. This competitive and innovative market is currently supported by a regulatory framework aimed at ensuring its smooth functioning. A key role in this process is intended to be played by the new European Database for Medical Devices (EUDAMED), a new IT system that is currently only partially functional, but when fully ready for use, “will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU)” [1].
Research on EUDAMED was conducted by Cyberethics Lab. within the context of the H2020 PERSIST Project while exploring the process that the PERSIST technology must go through to be placed on the market as a medical device. Based on the study’s results, the following information is provided for a better understanding of the functioning of EUDAMED and preparation for its full release.
The background and purposes of its creation
Actually, EUDAMED entered into force in May 2011. However, at that time it was only a central repository of information for the exchange between national competent authorities and the European Commission.
The prerequisite for the creation of a new, much wider European Database for Medical Devices was the changes introduced by the new regulations, namely the Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746). As a result, not only national competent authorities and the European Commission will have access to it, but also Notified Bodies, Economic Operators (Manufacturers, Authorised Representatives, Importers), and partly the public. Additionally, EUDAMED, as one of the key aspects of the new rules on medical devices, is intended to improve coordination and change for better communication between different EU Member States.
The duty to develop a new database was assigned to the European Commission (EC). In particular, Article 33 of MDR requires the EC to “set up, maintain and manage the European database on medical devices” [2].
To implement its tasks, the EC published Implementing Regulation (EU) 2021/2078 on 26th November 2021, which lays down the rules for the application of Regulation (EU) 2017/745 [3].
How will it function and what is its structure?
Technically, EUDAMED does not introduce new technologies, nevertheless, its processes will require updating knowledge from the health industry players.
In accordance with the EUDAMED information page, “it is a collaborative and interoperable platform, that will function as a registration system, a collaborative and a dissemination system (partially open to the public)” [4].
The database is structured around 6 interconnected modules, such as:
- Actors registration. It is intended for manufacturers, authorised representatives, and importers in order to register and obtain a Single Registration Number (SRN).
- UDI/Devices registration. The manufacturer will submit here the medical device information, associating it with a Unique Device Identifier (UDI).
- Notified Bodies and Certificates. All certificates issued by Notified Bodies are stored in this module, including changes and updates. In addition, information about suspended, restored, withdrawn or refused certificates will also be available here.
- Clinical Investigations and performance studies. This module will be used to manage clinical investigation and performance evaluation data. The sponsor will populate the database with information and provide final research reports. And the competent authorities can also enter data and change the status of the study.
- Vigilance and post-market surveillance. It will be used to send certain reports, including incident reports (Periodic Safety Update Reports; Periodic Summary Reports; Reporting of Serious Incidents; Field Safety Corrective Actions and Field Safety Notices).
- Market Surveillance. This module will function to facilitate cooperation and coordination between the competent authorities of the EU Member States. It allows Member States to upload information such as a summary of market surveillance results; reports on devices that present an unacceptable risk; reviews of its market surveillance activities and more.
What is the EUDAMED timeline?
Initially, EUDAMED was planned to be launched in May 2020, but in 2019 the Commission postponed its launch for another 2 years, outlining it’s a phased rollout. However, in December 2020, the “Actor registration” module went live, and later, in October 2021, the “UDI/device and Notified Body and Certificate” registration modules. All these 3 modules are not mandatory at the moment but can be used on a volunteer basis.
The other three modules (“Clinical Investigations and performance studies”, “Vigilance and post-market surveillance”, and “Market Surveillance”) are under development and will be released when all 6 modules of EUDAMED are declared fully functional.
On July 6, 2022, the European Commission published a timetable for EUDAMED development, audit and launch activities [5].
Data protection and EUDAMED
EUDAMED is subject to the requirements of the General Data Protection Regulation (GDPR) as a system that will involve personal data for its functioning.
In order to achieve compliance with the GDPR, in the MDR, in particular Article 33, states the following:
- EUDAMED shall contain personal data only insofar as necessary for the electronic systems (modules) to collate and process information.
- The personal data shall be kept in a form which permits the identification of data subjects for the shortest possible periods.
- The subject whose personal data is stored on EUDAMED can exercise his/her right of access to any data concerning him/her, as well as the right to correct and erase any inaccurate or incomplete data.
- Corrections and deletions shall be carried out as soon as possible, but no later than 60 days after a request is made by a data subject.
- The EC shall be considered the controller of EUDAMED [2].
The work on the development and implementation of EUDAMED is a priority for the European Commission. A series of delays, slowing its entry online, gave all parties involved time to properly prepare for the release of the database. In particular, manufacturers are recommended to take advantage of this delay and figure out the search function, they can also start registration in the first two modules voluntarily. In addition, it is worth considering how they will collect Post-Marketing Surveillance data.
However, with EUDAMED as a centralized database, competent authorities will be able to identify and recall defective medical devices faster and easier, improving patient safety. Doctors and other healthcare professionals, in turn, will also be better informed about any problems with the device. As for patients, they will be able to access information about the recalled devices using the UDI. In addition, the new database will eliminate redundant processes in the manufacturer’s work, relatively speaking by reducing “the number of papers”, when selling medical devices in several European countries. And this is only a superficial list of benefits that players will receive using the EUDAMED.
SOURCES
[1] T. E. Commission, «EUDAMED database,» [Online]. Available: https://ec.europa.eu/tools/eudamed/#/screen/home.
[2] E. P. a. Council, «Medical Device Regulation 17/745,» 2017. [Online]. Available: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN.
[3] T. E. COMMISSION, «COMMISSION IMPLEMENTING REGULATION (EU) 2021/2078,» 2021. [Online]. Available: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R2078&qid=1672217979410&from=en.
[4] T. E. Commission, «Public Health,» [Online]. Available: https://health.ec.europa.eu/medical-devices-eudamed/overview_en.
[5] T. E. Commission, «EUDAMED Time line,» [Online]. Available: https://health.ec.europa.eu/system/files/2022-07/md_eudamed_timeline_en.pdf.
[6] E. Commission, «EUDAMED database,» [Online]. Available: https://ec.europa.eu/tools/eudamed/#/screen/home.
This article is part of a project that has received funding from the European Union’s Horizon 2020 research and innovation programme under Grant Agreement No. 875406
