Dáil Éireann Debate, Tuesday - 7 November 2017
845. Deputy Louise O'Reilly asked the Minister for Health the procedure when a device is reported to the Health Products Regulatory Authority, HPRA; if the HPRA has the power to have a medical device removed from the Irish market; if not, the reason therefor; his views on whether this is putting persons at risk; and if he will make a statement on the matter. [46976/17]
Amharc ar fhreagraThe Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines and medical devices in Ireland. Its role is to monitor the safety of medical devices and to ensure the manufacturer takes any necessary measures relating to their devices so they can be used safely without posing unnecessary risk to patient or user health. The HPRA has the powers to take all appropriate measures to withdraw devices from the market or prohibit or restrict their being placed on the market or put into service. Under S.I. No. 444/2001 - European Communities (Medical Devices) (Amendment) Regulations, 2001, where the ‘Competent Authority considers that, in order to ensure protection of health and safety or to ensure that public health requirements are observed in accordance with Article 36 of the Treaty of Rome, the availability of any device should be prohibited, restricted or subjected to any particular requirements, it may give a temporary direction to that effect’.
