Full definition
EU MDR (Medical Device Regulation, Regulation 2017/745) is the EU's comprehensive medical-device regulation, in force from May 2021. Replaced the older Medical Device Directive (MDD). MDR significantly tightens requirements vs the prior framework: stricter classification rules, expanded post-market surveillance, more rigorous clinical evidence, increased Notified Body scrutiny, and explicit inclusion of software (SaMD) and AI features.
For healthcare technology procurement in EU: any software performing medical functions (diagnostic AI, decision-support that crosses certain thresholds, clinical-grade wearables) requires CE marking under MDR. EU AI Act adds another regulatory layer for high-risk AI in healthcare. The combined effect: EU healthcare AI procurement requires MDR + AI Act compliance demonstration from vendors.
Where eu mdr (medical device regulation) is used
- Software as Medical Device (SaMD) in EU/EEA
- Clinical-decision-support tools
- Connected medical devices
- Diagnostic apps and AI
- Wearables performing medical-grade measurement
Types of eu mdr (medical device regulation)
Class I
Lowest risk — self-certification.
Class IIa
Low-medium risk.
Class IIb
Medium-high risk.
Class III
Highest risk.
CE marking
Mandatory mark indicating MDR conformity for sale in EU/EEA.
Notified Body
Designated body that audits and certifies higher-risk devices.
EUDAMED
EU database for medical device registration and post-market surveillance.
Quantified benefits
- ▸Patient safety in EU
- ▸Harmonised regulation across member states
- ▸Mandatory post-market surveillance
- ▸Clinical evidence requirement strengthens validity
Frequently asked
Is MDR stricter than the old MDD?+
Yes — significantly. Stricter classification, expanded post-market surveillance, more rigorous clinical evidence, increased Notified Body scrutiny.
Is MOVO-X CE-marked?+
Features that fall under MDR scope have appropriate classification and CE marking pursuit. Most decision-support that augments clinician judgment falls below threshold. We work with customer regulatory affairs on specific deployments.
EU AI Act interaction with MDR?+
EU AI Act adds requirements on top of MDR for high-risk AI in healthcare. Both apply; vendors must demonstrate compliance with both frameworks.
What's EUDAMED?+
The EU database for medical device registration and post-market surveillance. Public registry showing certified devices and incident reports.