PART IIGENERAL PRINCIPLES

Scope and Exclusions

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.

Essential Requirements

4.—(1) Apparatus when properly installed and maintained and used for its intended purpose shall satisfy the essential requirements set out in this regulation.

(2) The following essential requirements shall apply to all apparatus:

(a)the protection of the health and safety of the user and any other person, including the objectives with respect to safety requirements contained in Council Directive 73/23/EEC(9) (but as if there were no voltage limit);

(b)the protection requirements with respect to electromagnetic compatibility contained in Council Directive 89/336/EEC(10);

(3) In addition, radio equipment shall be so constructed that it effectively uses the spectrum allocated to terrestrial/space radio communication and orbital resources so as to avoid harmful interference.

(4) When a measure has been adopted by the Commission pursuant to Articles 3.3, 6.2 and 15 of the Directive and published in the Official Journal of the European Communities determining that apparatus shall be so constructed that—

(a)it interworks via networks with other apparatus and that it can be connected to interfaces of the appropriate type throughout the community; or that

(b)it does not harm the network or its functioning nor misuse network resources, thereby causing an unacceptable degradation of service; or that

(c)it incorporates safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected; or that

(d)it supports certain features ensuring avoidance of fraud; or that

(e)it supports certain features ensuring access to emergency services; or that

(f)it supports certain features in order to facilitate its use by users with a disability,

apparatus within the scope of that measure shall meet the requirements of that measure from the date specified in that measure.