A05 – Has the Pendulum Swung? The changing global medical device regulatory landscape

The Medical Device Directives are being replaced by the Medical Device Regulation – are you ready? Medical device manufacturers face new challenges when trying to access the European market as a result of the recent publication of the new Medical Device Regulation (MDR). The MDR will have a significant impact on clinical, preclinical and biocompatibility performance as well as other technical requirements. This session will provide some insight into the changes and new requirements.
Also influencing the global landscape is the initiation of the medical device single audit program (MDSAP), a global approach to auditing and monitoring the manufacturing of medical devices. The pilot programme was completed at the end of 2016 and MDSAP is now being implemented. What does this mean for manufacturers and sponsors?

Chairperson: Grant Bennett,  Chief Executive Officer, Brandwood Biomedical