INS 2017: EU MDR Will Bring Changes, But Devices With Solid Data Will Still Clear Hurdle
Executive Summary
A bumpy road may lie ahead for makers of high-risk implantable devices, such as neuromodulation technologies, with the advent of the EU Medical Device Regulation. Suzanne Halliday, from the notified body BSI, spoke to Medtech Insight from the International Neuromodulation Society annual meeting in Edinburgh, about key concerns with the regulation, and she offers advice to companies on how they can facilitate their transition towards the new regulatory environment.