In this webinar, two experts (including an expert from a notified body) answer the most pressing MDR questions.
Dr. Matthias Fink, Clinical Reviewer at TÜV SÜD (an MDR notified body) and Dona Occhipinti, Medical Affairs EU MDR Project Manager and Independent Consultant, dive into questions such as:
1) Do we always need to claim equivalence or just with a CE-marked device?
2) What are the implications of the MDR on clinical trials and for the investigators?
3) What is the difference between the Clinical Development Plan and Post Market Clinical Follow-up Plan? (Annex XIV MDR)