EU MDR
EU MDR data terms
Scope
These terms add to the main MedTech Signal Terms of use and apply to the EU MDR module, including EU search, the EU dashboard, certificate expiry and EU answers in Ask AI. If they conflict, these terms apply to EU data only.
Where the data comes from
EU records are copied from EUDAMED, the European Commission's public medical device database, covering devices (UDI-DI), notified body certificates, and manufacturers identified by their registration number (SRN). Each record links back to its EUDAMED page, which remains the authoritative version.
Limits of EU records
EUDAMED registration is not yet mandatory for every device and our import is still filling in lower-risk classes. A missing EU record means only "no apparent EU match". It never means a device is not on the EU market, not CE marked, or not certified. Links to FDA and Health Canada records are marked "Possible match" until a person reviews them.
Not legal or regulatory advice
EU data is provided for research and monitoring. Confirm any decision about certification, market access or vigilance against EUDAMED, the notified body, or the competent authority. Rubicon Microproducts Inc. is not responsible for errors or delays in EUDAMED itself.
Reuse
You may use EU records inside your organization and quote them with a link to the EUDAMED source. You may not resell bulk extracts of the EU database or present them as an official European Commission service. EUDAMED content remains subject to the European Commission's own reuse conditions.
Access
The EU MDR module is included in Professional and Enterprise plans. Payments are handled by Paddle.com as merchant of record, as described in the main terms.
See also the main Terms of use, the EU MDR privacy notice and the EU MDR topic page.