Medical device
Short definition
A medical device is any instrument, apparatus, equipment, software or other article that the manufacturer intends for medical purposes, such as diagnosis, prevention, monitoring, treatment or alleviation of disease.
In plain language
The legal definition in the European Union is in Article 2, point 1, of Regulation (EU) 2017/745 (MDR). What counts is the purpose assigned by the manufacturer, not just the technology: the same equipment may or may not be a medical device depending on the stated purpose. Unlike a medicine, a medical device does not achieve its principal action by pharmacological, immunological or metabolic means.
In practice, in an RVer session
The RVer base product (the video library) is a Class I medical device registered with Infarmed.