The Electromagnetic Compatibility Regulations 2005

Medical devicesU.K.

This section has no associated Explanatory Memorandum

22.—(1) These Regulations do not apply to medical devices.

(2) Insofar as the Wireless Telegraphy (Control of Interference from Electro Medical Apparatus) Regulations 1963 M1 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 the manufacturer elects to comply with the Wireless Telegraphy (Control of Interference from Electro Medical Apparatus) Regulations 1963 if applicable.

(3) In this regulation “medical device” has the meaning given by Article 1.2(a) of Directive 93/42/EEC M2 concerning medical devices.

Marginal Citations

M2OJ No. L169, 12.7.93, p.1.