The Electromagnetic Compatibility (Amendment) Regulations 1994

Disapplication of the principal Regulations pursuant to Article 2.2 of the EMC Directive

6.—(1) For regulation 22 of the principal Regulations there shall be substituted the following—

“Medical devices

22.— (1) This regulation applies to medical devices first supplied in the Community on or after 30th December 1994 (hereinafter referred to as a “relevant medical device”).

(2) Subject to paragraph (3) below, on and before 13th June 1998, these Regulations apply to relevant medical devices.

(3) Paragraph (2) above shall not apply where either—

(a) both of the following conditions are satisfied—

(i) the manufacturer elects to comply with the Wireless Telegraphy (Control of Interference from Electro Medical Apparatus) Regulations 1963(1) if applicable; and

(ii) the relevant medical device

(aa) if required pursuant to any Community obligation other than the EMC Directive or the Medical Devices Directive to bear the CE mark or CE marking, neither bears nor is accompanied by any other indication, howsoever expressed, that it complies with either of those Directives; or

(bb) where sub-paragraph (aa) above does not apply, bears neither the CE mark nor the CE marking, nor any inscription likely to be confused with such mark or marking; or

(b) in relation to a device first supplied in the Community on or after 1st January 1995, the manufacturer elects to comply with the Medical Devices Directive and the device bears the CE marking.

(4) In so far as the Wireless Telegraphy (Control of Interference from Electro Medical Apparatus) Regulations 1963 impose electromagnetic compatibility requirements which must be complied with if a relevant medical device is to be supplied, used or taken into service, those Regulations shaLl cease to apply except where paragraph (3)(a)(i) above applies.

(5) In—

(a) this regulation, “Medical Devices Directive” means Council Directive 93/42/EEC concerning medical devices(2); and

(b) this regulation and in regulations 3 and 11, “medical device” has the meaning given by Article 1.2(a) of the Medical Devices Directive.”.

(2) For regulation 27 of the principal Regulations there shall be substituted the following regulation—

“Telecommunications terminal equipment and satellite earth station equipment

27.— (1) Nothing in these Regulations shall impose electromagnetic compatibility requirements in so far as such requirements are specific to any description of telecommunications terminal equipment or satellite earth station equipment.

(2) For the purposes of paragraph (1) above, electromagnetic compatibility requirements shall be taken to be specific—

(a) to a description of telecommunications terminal equipment, if that equipment is required to satisfy those requirements pursuant to Article 4(c) of the Telecommunications Terminal Equipment Directive; and

(b) to a description of satellite earth station equipment, if that equipment is required to satisfy those requirements pursuant to Article 4(c) of the Telecommunications Terminal Equipment Directive as extended to such equipment by Article 4.4 of the Satellite Earth Station Equipment Directive.

(3) In the application of these Regulations to telecommunications terminal equipment and satellite earth station equipment, these Regulations shall have effect as if—

(a) in regulation 31, paragraph (b) were omitted;

(b) in regulations 36 and 42, there were omitted in each case—

(i) from paragraph (1), the words “Subject to paragraph (2) below,”; and

(ii) the whole of paragraph (2) (the disapplication of the provisions of Parts IV and V to radiocommunication transmission apparatus); and

(c) the whole of Part VI (the EC type-examination route to compliance for radiocommunication transmission apparatus) were omitted.”.

(1)

S.I. 1963/1895.

(2)

OJ No. L169, 12.7.93, p.1. Article 22.4 provides for a transitional period until 13th June 1998 during which existing provisions may be complied with.