In vitro Diagnostic medical devices are classified into four main groups, those considered as general IVD medical devices, those coming within the classifications stated in Annex II List A and List B of the in vitro Diagnostic Medical Device Directive 98/79/EC (list A and list B), and devices for 'self-test' intended to be used by a lay person in the home environment.
Determination of the classification of an in vitro diagnostic medical device will depend upon the purpose of the IVD device and whether or not it is listed in Annex II.
The highest risk products are those in Annex II list A, followed by those in Annex II list B, then self-test and finally the 'general' category. The higher the risk the greater the level of assessment required by Notified Bodies. See also sections on Conformity Assessment and Notified Bodies.
