European Medical Device Regulation

(MDR) 2017/745

• Scope
• Framework Conditions
• Key Changes Introduced by the MDR
• Essential Safety and Performance Requirements
• Product Classification
• Process Standards (ISO 14971, ISO 13485, IEC 62366)
• Introduction to Clinical Evaluation
• Clinical Evaluation Plan (CEP)

Practical Task:

• Researching intended purpose, indications, patient group, and claims
• Preparing a Clinical Evaluation Plan