KEY POSTMARKET SURVEILLANCE CONSIDERATIONS FOR TRANSITIONING TO THE NEW EU MEDICAL DEVICE REGULATION

In light of recent approval of the EU Medical Device Regulation (MDR), manufacturers already in the European market must begin transitioning to meet the new expectation for continuous evaluation. In particular, the MDR elevates the importance of postmarket surveillance through manufacturer-mandated procedures to collect and review feedback from healthcare professionals and patients. A seasoned expert in the MDR will address the postmarket surveillance component and key steps manufacturers conducting business in Europe should take to adhere to the new regulation.

Speaker:
Laure Le Calvé
Avocat Associée
LCH Europe