Regulatory topic
EU MDR — what it means for your device portfolio
The EU Medical Device Regulation (EU) 2017/745 replaced the Medical Device Directive, with stricter clinical evidence, notified body oversight, UDI and post-market surveillance requirements.
Key MDR obligations
Manufacturers need a quality management system, technical documentation, clinical evaluation, a person responsible for regulatory compliance, UDI assignment, EUDAMED registration, and ongoing post-market surveillance and vigilance reporting.
Transition timelines
Regulation (EU) 2023/607 extended transition periods for legacy devices to 2027 or 2028 depending on risk class, provided conditions such as an MDR application to a notified body are met.
Where MedTech Signal fits today
MedTech Signal now imports EUDAMED's public device registrations and notified body certificates, and compares EU manufacturers and devices with FDA and Health Canada records. It also tracks recognized consensus standards (for example ISO 13485 and ISO 14971) that are also harmonized under the MDR.
Software under the MDR (Rule 11)
MDR Rule 11 classes most standalone medical software by the severity of the decisions it informs — many apps that were Class I under the old Directive moved up under the MDR. MedTech Signal's EUDAMED search lets you filter software devices by risk class and manufacturer, and the standards register tracks the software lifecycle standards (IEC 62304, IEC 82304) the MDR harmonizes.
EU MDR tools
- Search EU devices and certificates by manufacturer, class and country
- EU MDR dashboard: active devices, new certificates, upcoming renewals
- EU data sources and last refresh dates
- My compliance dashboard: checklist progress, EU matches, FDA recalls and enforcement
- EU MDR FAQ: EUDAMED, MDR rules and CE marking
- EU MDR compliance checklist: registration, CE marking, clinical evaluation and surveillance
- EU MDR data terms
- EU MDR privacy notice
EUDAMED devices and notified body certificates are imported and refreshed on a schedule (the full device list loads over several days, highest-risk classes first). EUDAMED registration is not yet mandatory for every device, so a missing EU record is never read as "not on the EU market".