Book II: FORMATION AND PERFORMANCE OF CONTRACTS

The medical devices listed in this section are medical devices within the meaning of Article 2 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices. The spare parts listed in this section are parts and components as defined in paragraph 1 of Article 23 of the same Regulation. The definitions in Article 2 of the same Regulation apply to the…

Manufacturers, importers and distributors of vehicles for the physically disabled, including electric scooters and walkers, shall ensure the availability of spare parts, in particular those listed as follows, for a minimum period of five years from the date on which the last unit of the model concerned was placed on the national market: a) Upholstery; b) Backrests; c) Headrests; d) Armrests; e) Armrests; f) Wheel supports ; g) Wheels including…

Manufacturers, importers and distributors of walking sticks and crutches shall ensure the availability of spare parts, in particular those listed below, for a minimum period of five years from the date on which the last unit of the model concerned was placed on the national market: tips. The provisions of this article shall not apply to parts that could not be used to maintain the intended purpose of this equipment…

Manufacturers, importers and distributors of electric or electronic blood pressure monitors and thermometers shall ensure the availability of spare parts, in particular those listed as follows, for a minimum period of five years from the date on which the last unit of the model concerned was placed on the national market: a) Cuffs; b) Batteries; c) Chargers. The provisions of this article do not apply to parts that could not…

Manufacturers, importers and distributors of sit-to-stand lifts shall ensure the availability of spare parts, in particular those listed as follows, for a minimum period of five years from the date on which the last unit of the model concerned was placed on the national market: a) Lifting arms; b) Handles; c) Shin supports; d) Subrotal support bands ; e) Sub-trotal support foams; f) Anti-slip pads; g) Heel wedges; h) Feet;…

Manufacturers, importers and distributors of production shell seats shall ensure the availability of spare parts, in particular those listed as follows, for a minimum period of five years from the date on which the last unit of the model concerned was placed on the national market: a) Backrests, including cervico-cephalic supports and thoraco-lumbar supports; b) Leg rests; c) Foot rests; d) Leg rest cushions; e) Wheels; f) Brakes; g) Harnesses….

Manufacturers, importers and distributors of patient lifting equipment shall ensure the availability of spare parts, in particular those listed as follows, for a minimum period of five years from the date on which the last unit of the model concerned was placed on the national market: a) Lifting arms; b) Flails; c) Feet; d) Foot spreader pedals; e) Foot spreader systems ; f) Batteries; g) Control boxes; h) Twin and…