An tOrd Gnó - Order of Business
Seanad Éireann — 2022-10-06
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Paddy Burke (FG), Agricultural Panel

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.

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Record URI: https://data.oireachtas.ie/akn/ie/debateRecord/seanad/2022-10-06/debate/main
Retrieved: 2026-08-14T04:51:08+00:00
Sitting date: 2022-10-06