The Medical Devices Introductory Course 2020

Overview of MEDDEV 2.7/1 rev. 4

• Provides much more detailed, clearer guidance than rev. 3 to manufacturers and Notified Bodies (NBs) • Presents a uniform, state of the art, scientific method to conduct a clinical evaluation • Requires thorough, complete and unbiased explanations, and justification for every conclusion • Manufacturers expected to improve the quality of all their CERs • NBs are expected to be much more critical of the data presented

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Transitioning to MDR

• MDR Article 10 (3) ” Manufacturers shall conduct a clinical evaluation in accordance with the requirements set up in Article 61 and Annex XIV, including a PMCF ” • Clinical evaluation is a critical element of MDR compliance • Manufacturers presented with a challenge in gathering sufficient clinical data to support safety and performance • MEDDEV 2.7/1 rev. 4 guidance represents a useful first step towards compliance with MDR’s more stringent clinical data requirements • Not entirely aligned with MDR • Not legally binding – MDR takes precedence

”Clinical evaluation” mentioned 129 times in MDR

The Organisation for Professionals in Regulatory Affairs