Billy Kelleher (Cork North Central, Fianna Fail)
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Question 634: To ask the Minister for Health if in view of the PIP scandal it is his intention to introduce a regulatory body to govern medical devices; and if he will make a statement on the matter. [16799/12]

Róisín Shortall (Dublin North West, Labour)
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The Irish Medicines Board (IMB) is the competent authority for medical devices in Ireland, however the IMB has no direct role in the authorisation of any medical device before it is placed on the market. Its role is to regulate the post- market surveillance of medical devices by working as part of a European network in order to identify emerging trends and safety issues and ensure that all safety information is communicated to patients, users and healthcare professionals. In relation to PIPs implants, the IMB has been closely monitoring the situation in liaison with European organisations and continues to provide up to date advice and information on its website. The regulatory framework for medical devices is currently being reviewed by the EU Commission. The purpose of this review is to strengthen legislation regulating medical devices, including the proposal of an appropriate regulatory structure or body for medical devices at EU level. The EU Commission expects to publish its proposals for new medical devices legislation later this year. The regulatory framework, including the respective roles of the IMB and Irish notified body, will be required to comply with this legislation. Both my Department and the IMB are fully committed to the initiatives proposed by the EU Commission and the IMB will continue to play a key role as the competent authority for medical devices in Ireland.