Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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435. To ask the Minister for Health further to Parliamentary Question No. 455 of 25 October 2016, the status of his Department's examination into the fact that the Health Products Regulatory Authority, HPRA, has stated that it is currently unable to enforce the European medical devices directive (93/42/EEC) for the provision of custom made devices due to the fact there is no link between the EU legislation and Ireland's current dental legislation; if a decision has been made as to whether he will ensure that the new dental Bill will include the provisions necessary for the HPRA to enforce the European medical devices directive; and if he will make a statement on the matter. [34417/16]

Simon Harris (Wicklow, Fine Gael)
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My Department, in conjunction with the Health Products Regulatory Authority, is currently examining the issues raised by the Deputy. No decision has been made on whether amending the Dental Act is the appropriate action.