EU MDR
European Medical Device Regulation
EU regulation for medical devices including Software as a Medical Device (SaMD). Requires CE marking, clinical evaluation, and quality management for healthcare software sold in the EU.
EU Commission — Software as Medical DeviceMarket withdrawal, CE marking revocation, criminal penalties per member state
12 to 24 months for full EU MDR compliance and CE marking
Generated code includes documentation templates, risk management patterns, and traceability — reducing compliance timeline
The EU Medical Device Regulation (MDR 2017/745) replaced the previous Medical Device Directive and significantly increased requirements for software qualifying as a medical device. Healthcare apps that provide diagnosis, monitoring, prediction, or treatment recommendations may qualify as SaMD under the EU MDR. The regulation requires a comprehensive quality management system (ISO 13485), clinical evaluation, post-market surveillance, and CE marking before the software can be placed on the EU market.
What It Covers
Classification of software as medical device (Rule 11) — Class I, IIa, IIb, or III
Quality Management System — ISO 13485 certification required
Clinical evaluation — evidence of safety and performance
Technical documentation — design dossier, risk management (ISO 14971)
Post-market surveillance — vigilance, adverse event reporting, PSUR
CE marking — conformity assessment before market placement
Penalties & Enforcement
CE marking revocation — product banned from EU market
Market withdrawal and product recall orders
Criminal penalties defined by individual EU member states
Notified Body audit failures block market access
Adverse event reporting failures trigger regulatory investigation
How VertiComply Helps
Documentation templates for technical files and design dossiers
Risk management patterns aligned with ISO 14971
Quality management workflows supporting ISO 13485
Post-market surveillance data collection patterns
Traceability from requirements to implementation to testing
Frequently Asked Questions
Does my healthcare app need EU MDR compliance?
If your app provides diagnosis, monitoring, prediction, or treatment recommendations for patients in the EU, it likely qualifies as SaMD under Rule 11 and needs EU MDR compliance including CE marking.
What is the difference between EU MDR and FDA SaMD?
Both regulate software medical devices but with different classification systems and processes. EU MDR uses Rule 11 classification (I to III), FDA uses De Novo, 510(k), or PMA pathways. Many companies pursue both for global market access.
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Quick Facts
Region
European Union
Category
Medical Device
Max Penalty
Market withdrawal,
Manual Timeline
12 to 24 months
With VertiComply
Minutes