Section 2: Definitions

For the purposes of this Title, the following definitions shall apply 1° Intended use means the use for which a medical device is intended according to the information provided by the manufacturer in the labelling, the instruction leaflet or promotional material; 2° Placing on the market: the first making available, whether in return for payment or free of charge, of a medical device, other than one intended for clinical investigations,…

For the purposes of this Title, the following definitions shall apply 1° Operator of a medical device: any natural or legal person who assumes legal responsibility for the activity requiring the use of this device or who makes this device accessible to third parties; 2° Maintenance of a medical device: all the activities intended to maintain or restore a medical device in a given state or in given conditions of…

A custom-made device is any medical device manufactured specifically in accordance with the written prescription of a duly qualified practitioner, or any other person who is authorised to do so by virtue of his professional qualifications, and intended to be used only for a specific patient. The written prescription referred to in the previous paragraph indicates, under the responsibility of the person who drew it up, the specific design characteristics…