Module 15 2022

19/05/2022

The Clinical Evaluation Team

Who should perform the clinical evaluation? MEDDEV 2.7.1 section 6.4

A suitably qualified individual or team with knowledge of:  Research methodology, regulatory requirements, medical writing etc.  The device technology: diagnosis and management of the relevant clinical condition (e.g., specialist clinical expert) and  Relevant degree and 5 years professional experience, or  10 years professional experience (if degree not needed for task)

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

17

The Clinical Evaluation Team

Who should perform the clinical evaluation? MEDDEV 2.7.1 section 6.4

● Manufacturer defines requirements and justifies choice ● Evaluators’ qualifications and experience documented ● Evaluator declarations of interest (App. A.11) • Relevant financial interests (e.g., employment, shares, study investigator) • Signed and dated by evaluator and manufacturer • Held by the manufacturer

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

18

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