Medical Device Regulation in European Union
EU Medical Devices Regulation (MDR 2017/745) and IVDR 2017/746 govern medical devices across all 27 member states. Conformity is demonstrated via CE marking, involving Notified Bodies for higher-risk devices, and tracked through EUDAMED. The MDR represents a significant tightening vs. the former MDD.
Recent Regulatory Updates
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Second EMDN training recording now available.
New standardized AER terminology with codes.
EU MD conference reviews regulatory revisions
Sources Tracked by Qalico
Qalico continuously monitors 169 references across guidelines, regulations, and standards for European Union.
Regulations
Guidelines
Device Classification
Based on 22 classification rules in Annex VIII. Class I: low risk, self-declaration (sterile/measuring variants require Notified Body). Class IIa/IIb: medium risk, Notified Body required. Class III: high risk (implantables, cardiac devices), strictest scrutiny. IVDs have separate Classes A–D under IVDR.
Official classification guidance →Official Regulatory Bodies
Official Guidance Documents
Official MDCG guidance on clinical evaluation, classification, labeling, UDI, and more.
Official EU Official Journal text of the Medical Devices Regulation.
European database for device registration, UDI, certificates, and vigilance.
Standards & Key Principles
Applicable Standards
Key Principles
- General Safety and Performance Requirements (GSPR) — Annex I of MDR
- Clinical Evaluation based on clinical evidence (Annex XIV)
- CE marking as EU market access passport
- UDI registration in EUDAMED for full traceability
- Post-Market Clinical Follow-up (PMCF) as a continuous activity
- Transparency via publicly available SSCP for Class III devices
Pre-Market Requirements
Comprehensive package covering device description, classification, design/manufacturing, GSPR compliance, risk management, and clinical evaluation. Required for all classes.
Mandatory for Class IIa, IIb, and III. Notified Body reviews Technical Documentation and QMS (ISO 13485). Class III requires additional scrutiny procedures.
Class III and some Class IIb implantables may require prospective clinical investigations where existing clinical data is insufficient.
Manufacturer issues Declaration of Conformity and affixes CE mark. Device registered in EUDAMED before market placement.
Post-Market Requirements
Systematic procedure to collect and analyze post-market data. Required for all devices; intensity scales with risk class.
Class IIa: at least every 2 years. Class IIb/III: annually. Must be available to the Notified Body.
Ongoing clinical data collection to confirm safety/performance and detect emerging risks. Requires PMCF Plan and Evaluation Report.
Serious incidents reported to competent authorities: 15 days for serious injuries, 2 days for death. FSCAs communicated via Field Safety Notices.
Publicly available document required for Class III and Class IIb implantable devices. Updated annually.
International Recognition & Reliance
MedDO aligned with EU MDR; CE marking accepted with Swiss Authorized Representative requirements.
TITCK broadly aligns with EU MDR; CE marking accepted as basis for Turkish market access.
EEA countries fully adopt EU MDR and recognize CE marking as domestic compliance.
CE marking accepted for Great Britain market until June 2030 (transition period).