Search Functions in the European Medical Device Database EUDAMED

By Elizabeth Pugh and Evangeline Loh

As a sequel to our recent update on searches that can be performed in the U.S. FDA 510(k) database, Emergo by UL reports on medical device searches in the European database for medical devices, EUDAMED, with the device registration data that has already voluntarily been included.

The European Medical Devices Regulation 2017/745 (MDR) and the European In Vitro Diagnostic Device Regulation 2017/746 (IVDR)  introduced the publicly accessible European database for medical devices, EUDAMED. While the ACTORS Module was first released for voluntary use on December 1, 2020, to facilitate the application for Single Registration Numbers (SRN), EUDAMED and the six modules have been delayed. In 2024, Regulation 2024/1860 revised the legislative requirement that all modules be released at the same time.

Resources from the European Commission (EC) exist to support EUDAMED: Information Centre, Q&A document (November 2024, and an infographic (with timelines). Most recently, the EC hosted a one-day workshop (May 21) and will host additional workshops.

To date, there is no official date for when certain EUDAMED modules will become compulsory.

Searches in EUDAMED Medical Device Module

In the most recent version of the EUDAMED Medical Device Module, the public can now search on many fields in the Device Module. There are the usual fields: manufacturer, SRN, model, tradename, and risk classification. The database distinguishes between medical device, system and procedure pack. Fields also exist to search the data for UDI-DI, Basic UDI-DI,  medical purpose, European Medical Device Nomenclature (EMDN), and “device type.”

Searches in device type

The “device type” field (options are hidden unless left-clicked on the arrow), to highlight a few,  permits selection of one or multiple attributes (not an exhaustive list): active device, CMR substances, cells or substances of microbial origin, companion diagnostics, containing latex, contains substances considered medicinal products from human blood, contains substances considered medicinal products, endocrine disrupting substances, Class IIb implantable WET, implantable instrument, near-patient testing, self-testing, administer remove medicine, kit, measuring, new device, orthopedic, reagent, reusable surgical instrument, software and sterile.

Searches in multiple fields

In addition, it is possible to perform searches for multiple fields and device attributes. As an example, Emergo experts routinely search for both EMDN Code and device classification, as well as the device type attributes and classification.

Concluding remarks

The collection of data and accessibility to the public has tremendously improved the access to device data that has been voluntarily included in EUDAMED. While EUDAMED has been delayed, public access to device data in the EU is a welcome development. No longer do manufacturers and the public have to rely on information on device registration in member state Competent Authority registration databases.