The role of the European database “EUDAMED” and its functions for clinical trials
An essential aspect to reach the goals of Regulation EU 2017/745 on medical devices is the implementation of the European database (Eudamed) integrating different electronic systems in order to collect and process information on devices present on the market as well as on economic operators, notified bodies, clinical trials, vigilance and market surveillance.
Therefore, once it becomes finally operative, EUDAMED will have the following purposes:
- to enable the public to be adequately informed about devices placed on the market, the certificates issued by notified bodies and about the relevant economic operators;
- to enable unique identification of devices within the internal market and to facilitate their traceability;
- to enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical investigations to comply with obligations established by the regulation;
- to enable manufacturers to comply with the information obligations regarding incident reporting;
- to enable the competent authorities of the Member States and the Commission to carry out their tasks and to enhance the cooperation between them.
So far, three out of six modules are functioning. This means that the obligations provide for by the Regulation (EU) 2017/745 regarding the exchange of information on medical devices are not applicable yet: the modules on Clinical Investigations and performance studies, Vigilance and post-market surveillance, and Market Surveillance are still missing.
Electronic System for Clinical Investigations
In particular, the clinical investigations electronic system will enable to generate the unique identification number at European level, that will be used for all communications regarding the clinical investigations.
The system will be used as point of access for the submission of all applications or notifications of clinical investigations and for the exchange of information between Member States, Commission and Sponsors regarding clinical investigations, such as in the case of substantial amendments.
All information will be included inside it by the Sponsor at the end of clinical investigation, in case of temporary halt or early termination, including the clinical investigation report.
All reports of serious adverse events and defects of the devices occurring during a clinical investigation shall be registered into the electronic system.
In arranging the electronic system for clinical trial, interoperability with the EU database for clinical trials on medicinal products for human use will be ensured (article 81 of the (EU) Regulation no. 536/2014 of the European Parliament and the Council) regarding the combined clinical investigations of devices.
The information included in the system will be accessible at different levels, i.e. economic operators, sponsors, competent authorities. Some information will be also available to the public, unless information confidentiality is justified, wholly or partly, for reasons of personal data protection, for the protection of commercially-confidential information, or for the effective surveillance of the investigation carrying out by the concerned Member States.
In any case, no personal data of the subjects will be available to the public. According to the European Commission implementation plan, the development of EUDAMED will be concluded within the Q4 of 2023, while the database full operability should be reached in the Q2 of 2024.
Written by Sofia Tabacco and Felisiano Cipressi on 02/20/2023
