Vol. 461 No. 7
150 Mr. Lawlor asked the Minister for Health the current position regarding the implementation of the EU Medical Devices Directive of July 1993; the consideration, if any, he has given to the establishment of a Medical Devices Agency similar to that in Britain in order to ensure compliance with the Directive; and if he will make a statement on the matter. [3883/96]
Limerick East): The Medical Devices Directive 93/42/EEC was transposed into Irish law by my Department on 3 August 1994. 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 as such is responsible for the implementation and enforcement of these regulations. I have no plans at present to establish an agency as described by the Deputy but I am keeping the matter under review.
