Legislation and Medical Devices

Like all industries, the selling of Medical Devices is subject to legislation and monitoring. The law that Surgical Holdings have to comply with, in order to sell Medical Devices is the European Communities Council Directive 93/42/EEC.

Classification

The Medical Devices that we sell fall into 2 categories, which are defined by the Directive. Class I reusable surgical instruments and Class II implants.

The Directive lays down the classification rules for these two categories; Class I, which are reusable surgical instruments. They are re-usable and not left in the body, therefore the lowest risk. Implants (such as Kirschner Wires, Bone Pins, Plates and Screws) are at higher risk, at Class IIb. This is because they are implanted into the body (invasive) for a period of time (normally around 90 days), although are not active in the body, so are therefore still quite a low risk.

Devices that are used with the central circulatory system, heart or central nervous system are of course a high risk (Class III) and would be subject to more stringent controls.