MDR Requirements for Clinical Evaluation of Medical Devices

The Medical Device Regulation (MDR) introduced by the European Union (EU) requires robust clinical evaluation to ensure the safety and performance of medical devices before they are marketed.
What is Clinical Evaluation?
Clinical evaluation involves assessing clinical data to verify that a device is safe and effective. This includes using existing data or conducting new clinical investigations if necessary.
Key MDR Requirements:
•    Clinical Evaluation Plan (CEP)
A plan outlining how clinical data will be collected and analyzed, including reviewing scientific literature and possibly conducting new trials.
•    Systematic Literature Review
A thorough review of available clinical data from published literature to support the device’s safety and performance.
•    Clinical Investigations (if needed)
If existing data is insufficient, new clinical investigations must be conducted, following MDR guidelines.
•    Risk Management Integration
Clinical evaluation must integrate risk management to address potential device risks.
•    Post-Market Surveillance
Continuous monitoring of device safety and performance through post-market surveillance and follow-up studies.
Conclusion
MDR clinical evaluation ensures medical devices meet safety and performance standards. Manufacturers must focus on strong clinical evidence, risk management, and ongoing monitoring to ensure compliance and patient safety.