As a manufacturer of a vascular medical device, you must ensure that you meet the relevant regulatory requirements before placing your product onto the market.
It is critical to work with an EU Notified Body or UK Approved Body that understands the industry and has the experience to review and confirm your product’s readiness for market.
We truly understand the challenges medical devices manufacturers face in bringing compliant products to market efficiently and safely. We offer a range of flexible product review services providing you with efficient pathways to bring your product to market.
What is a vascular medical device?
A vascular medical device can be defined as a device that is used in the arteries and 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.
For more clarity on vascular and related medical devices, please refer to:
- Europe Medical Device Regulation (EU MDR) 2017/745
- Part II of the Medical Devices Regulations 2002 (as amended) for Great Britain
