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  • Medical Devices
    Technical Team

Vascular medical devices

Placing your vascular medical device on the market.

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
Our Experts

Meet our experts

We are experienced in working with apparatus, appliances, implants, instruments and other articles intended to be used in the vascular system.

  • Our Experts

    Maritza Carballo, Global Head of Vascular Medical Devices, BSI

    "We're passionate about ensuring that these complex, lifesaving medical devices perform as intended and, ultimately, are safe for use in patients."

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Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, we can help.

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