According to the Medical Devices Directive 93/42/EEC (Official Journal L 169) a “medical device” refers to any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
Medical devices must be labelled by the manufacturer. The label also includes information about whether the medical device is marketed as a single-use or multiple-use device. If the medical device is to be marketed for multiple-use, the manufacturer also has to state a method for reprocessing. However, not all medical devices that are “multiple-use” can or should be re-used because their functionality or hygienically correct condition after reprocessing them cannot be guaranteed. Even more confusingly, there are medical devices that are labelled “single-use” although they can be and are legally reprocessed according to validated procedures that guarantee that patient safety is not at risk. However, figures should not be overestimated: a test of 20,000 medical devices by the German reprocessing industry, for instance, revealed that only 16% of all devices labelled as “single-use” can be safely reprocessed.
There is often confusion between medical devices and other products of the health care sector:
In vitro diagnostic medical devices are a special sub-group of medical devices and pertain to reagents as well as instruments and equipment that are used to examine human tissue or substances for medical purposes. These devices are only used outside the human body to perform medical examinations on samples taken from a patient. They are used to perform research on illnesses such as AIDS or hepatitis, but also to perform glucose or pregnancy tests.
A medicinal product is a substance or combination of substances that is administered to the human body. Its aim is to treat or prevent disease in human beings, to make medical diagnosis or to restore, correct or modify physiological functions in the human body.
[Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products]
Advanced therapy medicinal products comprise gene therapy products (e.g. a DNA plasmid or human gene to proliferate arterial cells), somatic cell therapy products (e.g. cell lysates to counter renal cancer) and tissue engineered products (e.g. skin substitutes that merge with natural skin to treat venous ulcers and foot skin ulcers). Both gene therapy and somatic cell therapy products (classified as “medicinal products”) are currently regulated under the Medicinal Products Directive (2003/63/EC). A current commission proposal aims at establishing a harmonised EU regulatory framework for human tissue engineered products.
Each medical device has a life span of one to several thousand uses. The manufacturers label these medical devices as either single-use or multiple-use.
Contrary to what the word implies, "single-use" does not necessarily define the number of uses that are foreseen for the device. In many countries the labelling does not impede third parties to develop validated procedures which guarantee a safe re-use. If a validated procedure for the reprocessing and re-usability of a medical device has been demonstrated to a notified body, the single-use labelling will be considered as disproved. In these countries, medical devices are labelled as "single-use" if the original manufacturer does not demonstrate a validated procedure for a specified number of re-uses. The label “single use” limits the liability of the producer to the first use. Hereby "use" is defined as one medical operation which may include several applications (e.g. surgeries on both eyes).
Multiple-use devices are devices which are declared by the manufacturer as reusable. A multi-use product is a product that is designed as a reusable medical device and is correspondingly designed as such. These products can be cleaned and resterilised carrying out the validated procedure according to the manufacturers’ instructions that they are obliged to provide.
From the viewpoint of reprocessing in some countries, such as Germany, medical devices are being classified into so-called risk categories:
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