Clinical Evaluation and Technical Documentation

Clinical Evaluation

Clinical Evaluation and Technical Documentation are interrelated in medical devices MDR compliance and both are the back born of the compliance process.

Clinical evaluation is a methodologically sound procedure to collect, appraise and analyze clinical data related to a medical device and to assess there is sufficient clinical evidence to confirm compliance with the general safety and performance requirements of the device when it is used as intended by the manufacturer.

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It is done, initially to obtain CE marking of the device and for placing the device in the market but updated thereafter periodically as new information becomes available from ongoing research works or literature published.

Question 1: Are the two manufacturers have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis?

Question 2: the original clinical evaluation of that manufacturer device has been performed in compliance with the requirements of this Regulation. Has the manufacturer of the second device given clear evidence thereof to the notified body?