Vascular medical device compliance and regulations
The vascular system consists of the heart, as well as blood vessels that supply blood to the brain and vital organs of the human body. And for the purposes of medical device classification, the European System has defined the central circulatory system (CCS) to include the coronary arteries, the ascending and descending aorta, the pulmonary veins, and carotid arteries that supply blood to the brain.
Devices that are used to correct conditions affecting the CCS are considered High Risk or Class III devices and are subject to Notified Body review. The reviews are typically done through a Design Examination of the manufacturer’s technical documentation and must demonstrate that the resulting device is safe, performs as intended, and meets the Essential Requirements of the Medical Devices Directive (MDD).
Arteries and veins not included in the definition of the CCS are considered to be part of the peripheral vasculature. In general, devices used within the peripheral vasculature are deemed as lower risk and are usually classified as Class IIa; if the device is a long-term implant, however, it is categorized as Class IIb. In these cases, the manufacturer “self-declares” conformity to the MDD and maintains a technical file that demonstrates the device meets Essential Requirements of the MDD. The technical file is then reviewed by the Notified Body on an audit basis per the Directive.
Why choose BSI for your product compliance to the Medical Device Directives?
Our vascular team has over 275 years combined medical device design, development and manufacturing experience, as well as over 65 years of combined regulatory experience. The members of the team collectively hold more than 20 US patents for stents, drug eluting stents, vascular and endovascular grafts, related technologies and processing. We have 17 technical experts with degrees in:
Our team’s command of the complex design, development and manufacturing processes of vascular medical devices is marked by worldwide industry success with products that include:
Our vascular team also brings a high level of expertise to the design examination of Class III devices and technical file audits. Our success is achieved through a working knowledge of the development process and an intimate involvement in the manufacturing process. In addition, our vascular team has experience in performing risk analysis, process validations and animal studies, ensuring every BSI reviewer will be able to engage in a meaningful dialogue with the manufacturer on important design and manufacturing elements.