MDR/IVDR – CE Marking
MDR (EU 2017/745) and IVDR (EU 2017/746) regulate medical devices and in vitro diagnostic devices in the European market. CE Marking ensures that products meet strict safety, performance, and quality requirements before being placed in the EU market. It involves technical documentation, clinical/performance evidence, risk management, and conformity assessment with Notified Bodies.
Key Areas of Evaluation
- Device classification as per MDR / IVDR rules
- Clinical evaluation (MDR) / Performance evaluation (IVDR)
- Risk management in accordance with ISO 14971
- Technical documentation preparation and maintenance
- Conformity assessment via Notified Bodies
- Safety, performance, and usability validation
- Post-market surveillance (PMS) requirements
- CE Marking compliance for EU market access
Benefits to MDR/IVDR – CE Marking
- Faster access to European medical device market
- Improved patient safety and product reliability
- Reduced regulatory and compliance risks
- Structured and audit-ready documentation
- Higher acceptance rate from Notified Bodies
- Strong regulatory credibility across global markets
- Need More Information
Regulatory Compliance Support
Ensure full alignment with MDR (2017/745) and IVDR (2017/746) regulatory requirements for CE Marking approval.
Technical Documentation Development
Preparation of complete technical files including design data, manufacturing details, and regulatory evidence.
Clinical & Performance Evaluation
Support in clinical evaluation reports (CER) and performance evaluation reports (PER) required for submission.
Risk Management Implementation
Structured risk management process aligned with ISO 14971 to ensure product safety and compliance.
Notified Body Assistance
Guidance and coordination during conformity assessment and communication with Notified Bodies.
CE Marking Certification Support
End-to-end assistance to achieve CE Marking and enable smooth entry into the European market.