Classification

Classification of medical devices is based largely on risk but includes other factors such as the invasiveness of the device, the part of the body in which the device is used and the duration of use of the device.

Further information on the classification of medical devices can be found in:

(1) Guide to the Classification of a Medical Device
(2) Annex IX of Directive 93/42/EEC
(3) MEDDEV
(4) Custom-made devices

A manufacturer initially determines the classification of their product. In certain situations it may be difficult to determine if a product falls within the scope of the Medical Devices Directives or the Medicinal Products Directives. In this case the manufacturer may seek advice from the IMB with regard to whether the product in question is categorised as a medicine in accordance with Directive 2001/83/EC or as a medical device in accordance with Directive 93/42/EEC.

In order to decide which of the Directives apply the following points should be considered:

The intended purpose of the product taking into account the way the product is presented
The method by which the principle intended action is achieved

In the case of a medical device the principle intended action is typically fulfilled by physical means (including mechanical action, physical barrier, replacement of, or support to organs or body functions). The action of a medicine is typically achieved by pharmacological, immunological or metabolic means.

The Irish Medicines Board - www.imb.ie

Classification