PARIS – If no one else was in this space, investors might wonder what we are doing here. That is the rationale given by Gerard Brett, the CEO of Galway, Ireland-based Vivasure Medical Ltd. in response to the fierce competition emerging in the market for vascular closure devices (VCD) for the increasingly large incisions in femoral arteries made to accommodate advanced percutaneous interventions.
PARIS – The good news regarding the complete overhaul of Europe's medical device regulations (MDR) is that there will be a three-year transition period before they are fully applied. The bad news for many manufacturers is that will not be enough time to comply with the more restrictive rules that lead to a CE mark and open the door to the world's second-largest market for devices, which is projected to hit $74.65 billion globally by 2020.
Now that the drawn out and highly political process of shaping new legislation to reform the CE mark approval rules is over, manufacturers face the task of bringing products into conformance with the new Medical Device Regulations (MDR). Ahead of the debates and fine-tuning of the legislation that can be expected as Brussels pushes forward the new legislation, Medical Device Daily spoke with Gert Bos, a leading expert on EU regulations.