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, with a view to its distribution or use in a Member State of the European Union or a party to the Agreement on the European Economic Area, whether the device is new or refurbished;

3° Manufacturer: the natural or legal person responsible for the design, manufacture, packaging and labelling of a medical device with a view to placing it on the market in his own name, whether these operations are carried out by this person or on his behalf by another person; the obligations imposed on the manufacturer by virtue of this Title also apply to the natural or legal person who assembles, packages, processes, refurbishes or labels medical devices, or assigns prefabricated products the purpose of being used as medical devices, with a view to placing them on the market under his own name. They do not apply to a person who, without being a manufacturer, assembles or adapts devices already placed on the market for a specific patient, in accordance with their intended purpose;

4° Representative: any natural or legal person established in a Member State of the European Union or party to the Agreement on the European Economic Area who, having been expressly designated by the manufacturer, acts and may be contacted by the competent administrative authorities in place of the manufacturer with regard to the obligations imposed on the latter by this Title;

5° Distributor: any natural or legal person engaged in the storage of medical devices and their distribution or export, excluding sale to the public;

6° Putting into service means making available to the end user a medical device ready to be used for the first time on the Community market, in accordance with its intended purpose;

7° Accessory means any article which is specifically intended by its manufacturer to be used with a medical device in order to enable that device to be used in accordance with the manufacturer's intentions;

8° Import means the introduction into the territory of a Member State of the European Union or a party to the Agreement on the European Economic Area of a medical device from a third country with a view to placing it on the market;

9° Importer: any natural or legal person established in a Member State of the European Union or party to the Agreement on the European Economic Area who imports medical devices;

10° Clinical data: information relating to the safety and performance obtained during the clinical use of a device. Clinical data is derived from either:

a) clinical investigations of the device concerned ;

b) clinical investigations or other studies cited in the scientific literature of a similar device for which equivalence with the device concerned can be demonstrated;

c) published or unpublished reports of other clinical experience with the device concerned or a similar device for which equivalence with the device concerned can be demonstrated;

11° Single-use device means a device intended to be used only once for a single patient;

12° Subcategory of devices means a group of devices having common fields of use or a common technology;

13° Generic group of devices, a set of devices intended for an identical or similar use, or having a common technology allowing a generic classification of these devices which does not reflect their particular characteristics.