The Medical Device Regulations are now published and companies need to begin firming up their plans for transition to the new system. However, while the final text of the Regulation itself is complete, the Delegated and Implementing Acts still need to be written and final details of transition between the Directive and the Regulation are awaited. These are important issues where there is still much to learn.
This year’s ABHI regulatory conference covered these key topics with the aim of providing the most up-to-date information possible. Delegates heard from regulators, industry and notified bodies who gave their expert opinions and shared the benefit of their close involvement in the evolution of the MDR.
DLC's President, Dr Maria E. Donawa, was among the speakers this year, and she spoke on the subjects of 'Clinical Evaluation & Risk Management' and 'Post-market Surveillance'.
The conference was held at the offices of Norton Rose Fulbright, 3 More London Riverside, London SE1 2AQ. Further information can be found on the ABHI website.