EUDAMED database

What EUDAMED database is?

EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation 2017/746 on in vitro diagnosis medical devices. The new Regulations contain important improvements including a much larger EUDAMED database than the one that currently exists under the Medical Devices Directives (Eudamed2).

EUDAMED is the unified European medical products database. EUDAMED aims to improve transparency and coordination of information on medical devices available on the EU market.

How does it work?

EUDAMED is structured around 6 interconnected modules and a public website:

• Actors registration
• UDI/Devices registration
• Notified Bodies and Certificates
• Clinical Investigations and performance studies
• Vigilance and post-market surveillance
• Market Surveillance

One can search for medical products by manufacturer, by package number, by authorized representative, by importer and by barcode on the UDI packaging and by certificates. Every medical product listed there is sold throughout the Europe.

Who can access EUDAMED?

Once an actor is registered in EUDAMED with its first Local Actor Administrator (LAA) and has obtained an Actor ID/SRN, more users of this actor can request access to EUDAMED.

What is the state of play of the implementation of EUDAMED?

The module on Actor registration is available since December 2020. The module on UDI/device registration and the module on Certificates and Notified bodies are available for voluntary use since October 2021 except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities.

Launching the second and third modules continues the roll-out of the database, which was supposed to be ready by the original Medical Device Regulation date of application in 2020 but is now subject to a delayed, staggered launch.

The Commission has yet to share a timeline for the availability of the rest of the modules, stating only that they will be released when EUDAMED is fully functional. European officials have previously targeted a May 2022 launch for the medical device database.

The Summary of Safety and Clinical Performance – SSCP

The Summary of Safety and Clinical Performance (SSCP) is one of the requirements imposed by manufacturers by the European Commission in Medical Device Regulations (MDR) 2017/745 for implantable devices and class III devices. The SSCP is an external document that includes information about a medical device, a summary of the clinical data for the device, and a summary of possible therapeutic alternatives. The SSCP is intended to provide intended users (healthcare professionals, and if relevant patients) with an updated summary of the device’s safety, clinical data, and clinical performance.

In view of the continuing incomplete functioning of EUDAMED, in May 2021 there was endorsed the Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional (MDCG 2021-1 Rev.1). This document provides guidance to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED. In this document, in alternative solutions to submit and/or exchange information (as required under the MDR) to the Article 32, it is stated that the SSCP shall be made available to the public upon request without undue delay or the manufacturer shall specify where it is made available to the public. Also, as soon as the functionality is available in EUDAMED, the system may be used for the upload of the SSCP even before the notice of full functionality of EUDAMED has been published.

Bibliography:

https://ec.europa.eu/health/md_eudamed/overview_en | ec.europa.eu

https://www.medtechdive.com/news/european-commission-EU-2-modules-delayed-eudamed-database-MDR-IVDR/608044/ | medtechdive.com

https://ec.europa.eu/health/sites/default/files/md_sector/docs/2021-1_guidance-administrative-practices_en.pdf | ec.europa.eu

https://criterionedge.com/the-summary-of-safety-and-clinical-performance-sscp-provides-valuable-information-to-health-care-providers-patients-and-manufacturers/ | criterionedge.com

https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_user_access_requests_en.pdf | ec.europa.eu