- active implantable medical device
means an active implantable medical device within the meaning of point (c) of Article 1(2) of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices which is EEE.
- distributor
means any natural or legal person in the supply chain, who makes an EEE available on the market.
- EEE
means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1000 volts for alternating current and 1500 volts for direct current;
- finance agreement
means any loan, lease, hiring or deferred sale agreement or arrangement relating to any equipment whether or not the terms of that agreement or arrangement or any collateral agreement or arrangement provide that a transfer of ownership of that equipment will or may take place;
- in vitro diagnostic medical device
means an in vitro diagnostic device or accessory within the meaning of, respectively, point (b) or (c) of Article 1(2) of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices which is EEE;
- large-scale fixed installation
means a large-size combination of several types of apparatus and, where applicable, other devices, which:
- large-scale stationary industrial tools
means a large size assembly of machines, equipment, and/or components, functioning together for a specific application, permanently installed and de-installed by professionals at a given place, and used and maintained by professionals in an industrial manufacturing facility or research and development facility;
- making available on the market
means any supply of a product for distribution, consumption or use on the market of a Member State in the course of a commercial activity, whether in return for payment or free of charge;
- medical device
means a medical device or accessory within the meaning of, respectively, point (a) or (b) of Article 1(2) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices which is EEE;
- non-road mobile machinery
means machinery, with on-board power source, the operation of which requires either mobility or continuous or semi-continuous movement between a succession of fixed working locations while working;
- placing on the market
means the first making available of a product on the market within the territory of a Member State on a professional basis;
- producer
means any natural or legal person who, irrespective of the selling technique used, including distance communication within the meaning of Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts: Whoever exclusively provides financing under or pursuant to any finance agreement shall not be deemed to be a ‘producer’ unless he also acts as a producer within the meaning of points (i) to (iv);
- removal
means manual, mechanical, chemical or metallurgic handling with the result that hazardous substances, mixtures and components are contained in an identifiable stream or are an identifiable part of a stream within the treatment process.
- WEEE
means electrical or electronic equipment which is waste within the meaning of Article 3(1) of Directive 2008/98/EC, including all components, sub-assemblies and consumables which are part of the product at the time of discarding;