The lack of a uniform approach by the Member States of the EU regarding the classification of medical devices, and borderline issues with other product categories such as cosmetic products or medicinal products, requires a detailed analysis of these products and a tailored strategy for their placing on the EU market.
"Medical device" means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: (i) diagnosis, prevention, monitoring, treatment or alleviation of disease; (ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, (iii) investigation, replacement or modification of the anatomy or of a physiological process; (iv) control of conception. Medical devices do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
Medical devices are subject to the following rules, depending on their function: Directive 90/385 regarding active implantable medical devices, Directive 93/42 regarding medical devices and Directive 98/79 regarding in vitro diagnostic medical devices. Medical Devices are further divided into classes, depending on their risk category, and the need for a higher degree of intervention by the notified bodies in assessing them.
There are numerous Guidelines at EU level which touch on relevant topics such as classification or technical compliance with standards and requirements of the Medical devices Directives.