Catherine Murphy (Kildare North, Independent)
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Question 124: To ask the Minister for Health his plans to extend the remit of the Irish Medicines Board to cover the regulation of distributors in situations where implants are involved; and if he will make a statement on the matter. [27579/12]

Róisín Shortall (Dublin North West, Labour)
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Implants are regulated as medical devices. The regulatory framework for medical devices is set down in EU legislation which has been transposed into Irish law. Under the EU regulatory framework, medical devices may be placed on the market anywhere in the EU following certification by a notified body.

While the EU regulatory framework does not make specific provision regarding the regulation of distributors, there are obligations on manufacturers to have systems in place to ensure traceability of medical devices.

The regulatory framework for medical devices is currently being reviewed by the EU Commission. I understand that the revision, due to be published in September, will contain proposals in relation to the regulation of distributors. My Department, in conjunction with the Irish Medicines Board, has undertaken work on this issue and is currently awaiting publication of the EU proposals to ensure that any national legislation put in place is consistent with future EU regulation of medical device distributors.