Requirements for Clinical Evaluation under the EU MDR

Join Greenlight Guru and DQS for an advanced webinar focused on the regulatory and practical requirements for Clinical Evaluation under the EU Medical Device Regulation (MDR).

This session will provide clarity on current expectations and help you strengthen your clinical evaluation strategy from a Notified Body perspective.

Agenda

• Overview of the MDR Certification Process
• Technical Documentation Requirements
• GSPR and Harmonized Standards
• MDR Requirements for Clinical Evaluation
• Clinical Evaluation Report (CER): Outputs and Link to PMS

What You Will Learn

By attending this webinar, you will:

• Gain a solid understanding of MDR requirements for Clinical Evaluation
• See how different regulatory requirements connect (GSPR, PMS, Risk Management, etc.)
• Clarify key definitions and common misinterpretations
• Understand practical expectations from a Notified Body perspective
• Walk away with actionable insights to strengthen your Clinical Evaluation process