The new Clinical Evaluation Process: approaches and strategies

The new regulation (EU) 2017/745 introduces several changes in the life cycle of Medical Devices; in particular the Clinical Evaluation presents new aspects and requirements with the specific aim to improve, through a systematic approach of the process, the appraisal of the safety and efficacy of the devices.

MEDDEV2.7.1 Rev 4 summarizes processes and requirements that must be fulfill in order to achieve a suitable analysis.

Trough the personal experience in the recent application of the new regulation to the Clinical Evaluation of Class IIa devices, the presentation will introduce the principal changes that the Legal Manufacturer of a Medical Device should take care in order to fulfill the requirements for the achievement a compliant Technical File.

About the speaker
Fabio Macchi

Biography available soon

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