Clinical evaluation and PMCF for medical devices

Manufacturers of medical devices must carry out a clinical evaluation of their products in order to be authorised to market them in Europe. Based on the clinical data collected, the safety, performance and efficacy of the device must be proven. The manufacturer then assesses whether the risks of use are proportionate to the expected benefits. According to the MDR, the requirement for the manufacturer regarding the clinical evaluation does not end with the marketing authorisation of the device. In accordance with Annex XIV, post-market clinical follow-up (PMCF) is understood as an ongoing process to update the clinical evaluation.

This seminar will show you a way to prepare the clinical evaluation starting from the product idea and integrate it into the development process, as well as to derive the clinical follow-up. 

In this event, you will learn step by step which regulatory requirements you have to fulfil as a medical device manufacturer and how these are to be seen in the context of other processes such as risk management and development.

The theoretical principles are supplemented by concrete examples from the speaker's professional practice. 

In addition, the event format offers sufficient time for your questions and discussions. 

We look forward to your participation!

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