Dáil Éireann Debate, Tuesday - 7 November 2017
847. Deputy Louise O'Reilly asked the Minister for Health if transvaginal mesh devices underwent testing before coming onto the market here; the details and results respectively of the testing; and if he will make a statement on the matter. [46978/17]
Amharc ar fhreagraAll medical devices, including transvaginal mesh devices, are certified (CE marked) at European level prior to being placed on the market. For mesh devices as class IIb medical devices the products are certified by independent certification organisations, called notified bodies, who are required to have the necessary expertise to assess different types of device technologies. This EU-level assessment demonstrates that the devices comply with the Essential Requirements of the medical device legislation, including those relating to performance and safety. This certification is based on assessment of relevant testing, technical, pre-clinical and clinical data to demonstrate the technical characteristics and the clinical safety and performance of the device.
The Health Products Regulatory Authority (HPRA) is the competent authority for medical devices in Ireland. In accordance with the EU legislation it does not approve medical devices prior to their being placed on the Irish market, rather it has a post market surveillance role where they monitor the medical devices on the market. The approval of medical devices prior to their being placed on the market is carried out at European level by notified bodies. The HPRA does not have access to the specific details and results of testing conducted on individual devices as this information would normally be held by the EU notified body who certifies the device.
