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Classification

The directive applies different administrative requirements to devices depending on the risk which they present to the user. There are four classifications:

Class I - generally regarded as low risk
Class IIa - generally regarded as medium risk
Class IIb - generally regarded as medium risk
Class III - generally regarded as high risk.

Once it has been decided that a device falls within the scope of the Medical Devices Directive, the actual classification of an appliance is determined by a series of rules which are laid out in annex IV to the Directive. Essentially these start by saying that anything which is not covered by one of the other rules is a class I device, and then go on to give more detailed rules for the classification of other equipment. Typical factors upon which the rules decide are whether the device is intended for long term or short term use, whether it involves the use of associated pharmaceuticals and chemicals, whether it is invasive in normal bodily orifices or via surgical insertion, and whether it operates by the exchange of energy with the body. Definitions of terms used to describe these factors are also included in the annex.