Directive 98/97/EC applies to in vitro diagnostic medical devices and to their accessories that fit the following definitions
In vitro diagnostic medical device
Any medical device which is a reagent,reagent product,calibrator,control material,kit,instrument,apparatus,equipment,or system,whether used alone or in combination,intended by the manufacturer to be used in vitro for the examination of specimens,including blood and tissue donations,derived from the human body,solely or principally for the purpose of poviding information:
-concerning a physiological or pathological state,
Or - concerning a congenital abnormality,
Or - to determine the safty and compatibility with potential recipients,
Or - to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices."Specimen receptacles" are those devices,whether vacuum-type or not,specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
Products for general laboratory use are not in vitro diagnostic medical devices unless such products,in view of their characteristics,are specifically intended by their manufacturer to be used for in vitro diagnostic examination.
Accessory
Any article which,whilst not being an in vitro diagnostic medical device,is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose.
For the purposes of this definition,invasive sampling devices or those which are directly applied to the human body for the puopose of obtaining a specimen within the meanng of directive 93/42/EEC,shall not be considered to be accessories to in vitro diagnostic medical devices.