The Medical Devices Directive (93/42/EEC, as amended), as a general rule, applies to products making medical claims. A medical device is defined as;
...any equipment or other article, intended to be used for the purpose of:
- diagnosis, monitoring, treatment or alleviation; or prevention of disease; or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception.
The Directive (93/42/EEC, as amended) has been replaced by a new EU Regulation (No. 2017/745). The new Regulation shall apply from the 20th May 2020, however specific articles within the Regulation will apply before this date.