Notice type: Advisory
Medical devices can range from walking sticks to bone cement to pacemakers to in-vitro diagnostic kits. The range is broad and complex. Examples include surgical sutures, bandages, blood bags, irrigation solutions intended for mechanical rinsing, X-ray equipment, drug delivery pumps, HIV test kits, pregnancy test kits.
Under the Medical Devices Directive 93/42/EEC and the In-vitro Diagnostic Medical Devices Directive 98/79/EC, a manufacturer is obliged to provide adequate information that ensures the safe use of his device.
This information is usually provided in the format of either instructions for use (IFU) or the operating manual or in some cases both.
The instructions for use is therefore a key tool that professional users should use to determine the: