(EU) 2017/745 Medical Device Regulation
Transitioning from the MDD to the requirements of the MDR
Following the successful introduction to the MDR that was provided by Boston® Materials at last year’s EFCLIN event in Dubrovnik, we are delighted to provide you with a comprehensive guide to some of the key aspects of the transition work that is required in order to meet the requirements of the Medical Device Regulation. In this section our own MDR expert – Alan Bennett – provides an update on the materials testing work that has been completed over the past year, along with some additional guidance on the Substances of Very High Concern requirements. Alan, as one of the MDCG Expert working group members, has also provided some insights into the additional requirements for Post-market Surveillance and Vigilance.