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3.—(1) Subject to paragraphs (4) and (5), these Regulations shall apply to all apparatus.
(2) Where apparatus incorporates, as an integral part or as an accessory—
(a)a medical device; or
(b)an active implantable medical device,
nothing in these Regulations shall affect the application of Council Directive 93/42/EEC of 14 June 1993(1); or Council Directive 90/385/EEC of 20 June 1990(2); or the Medical Devices Regulations 1994(3); or the Active Implantable Medical Devices Regulations 1992(4).
(3) Where apparatus constitutes a component or a separate technical unit of a vehicle, nothing in these Regulations shall affect the application of Council Directive 72/245/EEC of 20 June 1972(5); or Council Directive 92/61/EEC of 30 June 1992(6); or the Motor Vehicles (Type Approval) Regulations 1980(7); or the Motorcycle (EC Type Approval) Regulations 1995(8).
(4) These Regulations shall not apply to apparatus exclusively used for the purposes of public security, defence, State security (including the economic well-being of the State) or the activities of the State in the area of criminal law.
(5) These Regulations shall not apply to equipment listed in Schedule 1.
OJL No. 169, 12.7.1993, p 1.
OJL No. 189, 20.7.1990, p 17.
OJL No. 152, 6.7.1972, p 15 as last amended by Commission Directive 95/54/EC (OJL 266.8.11.1995, p 1).
OJL No. 225, 10.8.1992, p 72.
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