The question of whether the benefit of a medical device is higher than the residual risk during use is essential for market approval. The answer results from the interaction between the processes of clinical evaluation and risk management. And this is precisely where things have been getting stuck for years, with ever-increasing consequences. It is clear that there must be an exchange of information between the processes. But the devil is in the details: In practice, many questions arise for which both manufacturers and notified bodies often have no clear answers.

This Tech-Talk addresses the following questions: 

• Which data must be exchanged between risk management and clinical evaluation?
• How can I create a traceability between information and ensure consistency?
• What is the relation of content in the
  • Clinical Evaluation Plan
  • Risk Management Plan
  • Clinical Evaluation Report
  • Risk Management Report
• What must be considered for an update of the Clinical Evaluation or Risk Management File during the post-market surveillance phase?
• What are current challenges in the industry for which we do not have a solution at the moment?