Background
According to European Commission a web-based portal EUDAMED is being developed to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. The system consists data on medical devices that have been collected and registered by Competent Authorities and the European Commission and can only be accessed by these same parties. The amount of data which will be available to the European Authorities through EUDAMED is the most significant changes being introduced by the new European Union Medical Device Regulations (EU MDR) Article 33. This data collection with EUDAMED was established by the Medical Device Directive (MDD) Article 14a. But the amount of data made available to the European Authorities has been minimal compared to what is envisaged in the new EU MDR. This ‘MDR EUDAMED’ is intended to provide more data, of higher quality and with a wider accessibility. EUDAMED aims at improving transparency and coordination of information regarding medical devices available on the EU market.
Database Access
The ‘MDR EUDAMED’ will not only be used by the National Competent Authorities (NCAs) and the European Commission. Depending on the type of user, only certain levels of the databank can be accessed. It will also be accessed by:
- Medical Devices Coordination Group (MDCG)
- Notified Bodies (NBs)
- Economic Operators (EOs – manufacturers, authorized representatives, importers, sponsors)
- Experts
- Non-European Competent Authorities (NCAs)
- And the public, including medical institutions and the press
Database Module
EUDAMED will function as a registration system, a collaborative system, a notification system, and a dissemination system (open to the public) and will be interoperable. EUDAMED is structured around 6 interconnected modules and a public website:
- Actors ((NCA’s, EOs, NB’s) registration
- UDI/Devices registration
- Notified Bodies and Certificates
- Clinical Investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance
One of the key objectives of the Medical Devices Regulation (MDR) is transparency aiming at providing a larger access to relevant information to the public and strengthening public and patient confidence in the safety of medical devices placed on the EU market. These obligations in MDR will be applicable once the EUDAMED is fully functional.
Key information accessible to the public in EUDAMED:
- Registration of all manufacturers, their authorized representatives and importers placing medical devices on the EU market
- Registration of devices, the core elements of the UDI database of part B of Annex VI, including the basic UDI and UDI-DI of devices
- Registration of certificates of conformity, their scope and validity period
- List of notified bodies designated under the MDR, their identification numbers and their conformity assessment activities through a link to NANDO database and the list of their subsidiaries
- Scientific opinions of the expert panels and the written justification of the notified body where it has not followed the scientific opinion of the expert panel
- Clinical investigation reports and their summary
- The summary of safety and clinical performance reports for implantable devices and class III devices
- Manufacturer incident reports (partial access) and the field safety notices for Vigilance activities
- Summary of the results of market surveillance activities on their national territory by each EU Member State.
Key information publicly available outside EUDAMED
- National measures taken by competent authorities for the placing on the market of single use devices which are reprocessed
- Types and levels of fees levied by Member States for funding activities carried out by the competent authorities
- National measures governing the assessment, designation, and notification of notified bodies
- List of standard fees from notified bodies
- Summary of each Member State report on its monitoring and on-site assessment activities regarding notified bodies
- Commission annual summary report of the peer review activities of authorities responsible for notified bodies,
- Declaration of interests of top-level management of notified bodies
- Declaration of interests of each member of the MDCG, of its sub-groups except for stakeholder organizations, and of the advisors within the expert panels and expert laboratories
- Advice provided by the expert panels
- Names and affiliation of the members of the MDCG.
Important EUDAMED Dates
For the EU Commission this development and implementation of EUDAMED is a high priority. And with help of MDCG, it is going to release different modules as soon as they become functional. Currently the deployment of Actor registration (first module) is planned for December 2020. The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module) will become available by May 2021. Afterwards, the remaining modules will be presented as soon as they are operational. Most of the requirements on Transparency and public access to information linked to the EUDAMED, are planned to become fully functional by May 2022. The official web address of the EUDAMED public website will be “ec.europa.eu/tools/eudamed”. It will be available once it is in production and not before.
Turacoz Healthcare Solutions understands medical device regulatory MDR requirements and can assist you in your device approval journey. Our technical writers are experienced industry experts having worked with EMA, FDA and other regulatory agencies in gap analysis, device approval and regulatory queries responses. In addition to the regulatory services, the team also provides publication, medi-marketing and advisory board meetings for medical device companies.
If you have any queries, email us at [email protected].
References
- https://ec.europa.eu/health/md_eudamed/overview_en
- https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/transparency_factsheet_en.pdf
