Vascular devices are medical devices and their accessories that are used in the arteries, veins or the heart itself, to control, diagnose, monitor, or correct disease, injury, or other conditions. This vasculature encompasses the cardiovascular, peripheral vascular, and neurovascular anatomy. These devices may be metallic or polymeric and may utilize animal tissues or be used in combination with medicinal substances.
Navigating the complex regulatory landscape is crucial for manufacturers of vascular and vascular access devices aiming to enter European and UK markets. Compliance with the Europe Medical Device Regulation (EU) 2017/745 is mandatory to obtain the CE Mark, while meeting the UK Medical Devices Regulations 2002 is required for the UK Conformity Assessed (UKCA) mark.
As an approved EU Notified Body and UK Approved Body, we provide comprehensive services to ensure your devices meet these rigorous standards – from certification to quality management system (QMS) certification and beyond.