John Ellis
Ceist:98 Mr. Ellis asked the Minister for Health the regulations regarding the operation of private ultra-sound examination facilities. [19107/96]
Vol. 470 No. 4
98 Mr. Ellis asked the Minister for Health the regulations regarding the operation of private ultra-sound examination facilities. [19107/96]
Limerick East): Ultrasound equipment falls within the scope of the Medical Devices Directive 93/42/EEC which was transposed into Irish law on 3 August 1994 and the implementing regulations, which are entitled the European Communities (Medical Devices) Regulations, 1994 (S.I. 252 of 1994) became effective on 1 January 1995. My Department is the competent authority for medical devices in this country and is responsible for the implementation and enforcement of these regulations.