Paddy Burke (Fine Gael) | Oireachtas source

I ask that the acting Leader invite into the House the European Commissioner with responsibility for regulation of the medtech area. Most Members of the House had a meeting yesterday with the Irish Medtech Association and IBEC regarding the approval of medical devices in Europe. There is a huge backlog in respect of the approval of all these medical devices.It will have a major effect on the European population because EU regulation systems put patient access to medtech at risk. These devices are not being approved, and others are being approved at a very slow pace. A lot of start-up companies are now looking to the USA where FDA approval is much quicker. This will have a significant effect on Ireland. In Mayo, we have Baxter, Allergan, Hollister and Meissner, to name just a few. In the Cathaoirleach's area of Galway, there are a huge number of medical device companies. This is putting jobs in Ireland, the people who need to use the medical devices and hospitals at risk. I ask that we consider inviting the Commissioner with responsibility for this area to the House so that we can determine where the backlog or hold-ups are regarding the approval rates which are one in four. It will take up to 2024 before the backlog is approved.