raps event

Clinical Evaluation: What have we learned and where can we find data?

As a result of the EU MDR coming into force, the complexity and requirements for clinical evaluation of medical devices have changed in Europe. In this webcast, one Notified Body clinical reviewer and two industry experts present their personal experiences around how to focus on these new challenges. They will present pitfalls and learnings from recent submissions to NB’s under EU MDR, and they will address solutions and possibilities to overcome these situations. Participants in the webcast will benefit from the hands-on sharing of experience from European experts and can engage in Q&A session at the end of the session.

This advanced level webcast is specifically aimed at global regulatory professionals, involved in regulatory submissions in the EU. A detailed knowledge on the clinical evaluation requirements of the EU Regulation 2017/745 and related MDCG guidance documents is expected from the participants to most optimally benefit from the experiences of the presenters.