The Medical Device Regulation (EU 2017/745 – MDR) is the European regulatory framework governing the design, production, CE marking, and post-market vigilancia of medical devices across the EU and EEA.
How Does EU MDR Affect Your Company?
MDR enforces strict lifecycle requirements, including rigorous clinical evaluation, comprehensive Technical Documentation, stricter software classification under Rule 11, mandatory PRRC appointment, and proactive Post-Market Surveillance (PMS).
Glaze Medical – Your MDR Compliance Partner
- Regulatory Strategy & Classification: Clear interpretation of MDR rules, MDCG guidance, and conformity assessment routes.
- Technical File & GSPR Documentation: Hands-on compilation and review of Annex I, II, and III deliverables.
- Quality Management Systems (QMS): Lean, compliant ISO 13485 QMS tailored to MDR Article 10(9).
- Clinical Evaluation & Risk Management: Alignment between intended purpose, ISO 14971 risk files, and Clinical Evaluation Reports (CER).
- Notified Body Audit Readiness: Internal audits, gap assessments, and pre-submission reviews.
Contact Glaze Medical for pragmatic, experienced support on your journey to MDR compliance.