a tool, instrument, device, software, material or other article, whether used alone or in combination, including software intended by its manufacturer for use specifically for diagnostic or therapeutic purposes and necessary for its proper use, intended by the manufacturer for human use for the purpose of:
(a) diagnosing, preventing, monitoring, treating or alleviating the course of the disease,
(b) diagnosing, monitoring, treating, mitigating or compensating for the effects of injury or impairment,
c) testing, replacing or modifying the anatomical structure or physiological process,
(d) the regulation of conception
– the essential intended action of which in the human body or body is not achieved by pharmacological, immunological or metabolic measures, but whose action may be assisted by such means.
In practice, this category covers a wide range of products that differ not only in nature, but also in terms of their complexity and application. The purpose of the example is to indicate that the group of medical devices includes, inter alia, medical thermometers, gleuctometers, dentures and implants.