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.