Vascular medical devices

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

The Vascular team specializes in any apparatus, appliance, implant, instrument, material or other article intended to be used in the arteries and veins that carry blood throughout the body or in the heart itself for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease or injury, or in the investigation, replacement or modification of the anatomy in relation to the vasculature or the heart.

We are experienced in working with manufacturers of apparatus, appliances, implants, instruments, materials, or other articles intended to be used in the arteries and veins that carry blood throughout the body.

Where products require additional expertise, we collaborate with our in-house clinicians and technical teams in all areas from active implantable, dental and orthopaedic, to medicinal substances, devices utilizing animal tissue, and sterile medical devices.

BSI is able to offer CE certification services under the EU MDR and UKCA services under the UK MDR 2002 for vascular medical devices. Examples of products we cover include:

• Cardiac electrophysiology and ablation catheters
• Catheters for intravascular and intracardiac imaging
• Devices for the treatment of Abdominal Aortic Aneurysms (AAA)
• Devices for the treatment of neurovascular diseases including catheters, embolic coils, flow diverters, stents, and wires
• Devices for treatment or repair of structural heart defects or disease
• Drug-eluting stents, bare metal stents, and bioresorbable stents
• Embolic filters and IVC filters
• Guide catheters, balloon catheters, CVCs, introducers, filters, guidewires, PICCs, and related tools
• Renal artery denervation devices
• Transcatheter and surgical valves and related accessories
• Vascular closure devices
• Vascular grafts (textile and ePTFE) and stent-grafts

For more clarity on vascular and related medical devices, please refer to the MDR (EU) 2017/745 and the UK MDR 2002.

Our team has a broad range of experience, including product design and development, manufacturing, sterilization, and product testing.

Our vascular technical specialists are product experts who are highly trained in working with vascular medical device manufacturers and understand the specifics of these complex devices. The team has an average of 20 years’ industry and regulatory experience.

BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.

Vascular medical devices are complex and the process of CE or UKCA marking these devices can be challenging; we regularly engage with manufacturers and provide guidance on the relevant technical requirements. For CE marking, we have developed MDR Best Practices Guidelines to assist with this.