Clare Daly (Dublin North, United Left)
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759. To ask the Minister for Health if he will request the Health Products Regulatory Authority's views on immunoglobulin G food intolerance testing; and if the authority is aware of any discussions taking place at European Union level regarding IgG food intolerance testing. [20820/15]

Kathleen Lynch (Cork North Central, Labour)
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The Health Products Regulatory Authority (HPRA) is the competent authority in Ireland for the regulation of medical devices, including in-vitro diagnostics (IVD) products such as food intolerance tests. This role involves post market surveillance of products that have been placed on the market and are in use.

The HPRA has no direct role in the authorisation of any medical device before it is placed on the market. Medical devices such as food intolerance tests can be placed on the European market once they bear a CE mark issued by an independent certification body known as a 'notified body'. The notified body carries out a conformity assessment to confirm that the devices meets specified safety and performance requirements. The HPRA does not approve or certify these devices for sale in Ireland or any other country, nor does it have a role in regulating the provision of food intolerance testing services by pharmacies, clinics and other entities that may be providing such services.

The HPRA issued a Medical Devices Information Notice on 24 March 2015 on Food Intolerance Testing. This Notice may be found on the HPRA website. The HPRA position, as set out in the Information Notice, is that the diagnosis of any condition relating to the ability to digest or "tolerate" foods should be made in careful consultation with a doctor who is familiar with the patient's health history and should not be based on the use of self testing alone. The HPRA does not recommend using these tests or interpreting results without this involvement as it may have negative health effects such as the removal of important food groups from an individual’s diet, or the potential misdiagnosis of a serious medical condition.

In January the HPRA commenced an active surveillance programme on food intolerance tests. This involves reviewing the performance and safety implications of the products and services available on the market. As part of this surveillance programme, the HPRA is cooperating with European regulatory partners, including the United Kindgom, as many of the products available in Ireland have been manufactured or received their CE mark from notified bodies in the United Kingdom.

At European level, the regulatory framework for medical devices is currently being reviewed. The purpose of this review is to strengthen the legislation including improvements to market surveillance and clinical evaluation of medical devices. The progression of this legislation is a priority for my Department and the HPRA.