Under the MDR, clinical evaluation must include an appraisal of clinical data to determine whether the evidence is suitable for establishing a device’s safety and performance. If the data are insufficient, CE marking can be delayed or put at risk. Methodological quality and scientific validity are central to that appraisal.

Manufacturers need to understand how their clinical data will be evaluated, what makes evidence suitable for its intended purpose, and how those conclusions should be documented in the Clinical Evaluation Report (CER).

On November 6, Maria E. Donawa, M.D., President of Donawa Lifescience, joins the MedTech Leading Voice EXCHANGE Friday In Focus session to explain how clinical data appraisal works under the MDR and what manufacturers should consider when designing studies to support CE marking.

Dr. Donawa will cover:

• What clinical study data must demonstrate to support CE marking under the MDR
• How clinical data appraisal determines whether evidence is suitable for establishing device safety and performance
• How methodological quality and scientific validity are assessed and documented in the CER
• What ISO 14155 says about the relationship between clinical evaluation and clinical study design
• How to address methodological quality and scientific validity when developing a clinical study protocol

Dr. Donawa will also discuss the current clinical evaluation guidance, including MEDDEV 2.7/1 Rev 4 and MDCG 2020-13, and note that updated guidance is being developed by the European Commission.

Click here for further details and registration instructions.