EU backlog hitting Mayo’s medtech sector hard

Mayo’s medical technology multi-national firms face an uncertain future due to a huge EU backlog in approving their new products and devices, The Connaught Telegraph has learned.

The serious situation, which has the potential to impact on healthcare, as well as a significant number of jobs, in the county has been outlined to Oireachtas members in the region.

Representatives of the Irish Medtech Association and IBEC have briefed Mayo TDs and senators at Leinster House.

They were informed that the slow pace of approvals will have a major effect because EU regulation systems are placing patient access to medtech at risk.

Senator Paddy Burke is seeking urgent action as many devices will not receive approval until 2024 at the earliest.

He outlined: “This is having a significant effect on Ireland. In Mayo, for example, we have Baxter, Allergan, Hollister and Meissner being impacted as a result of this situation.

“The same applies in Galway and Sligo where there are a huge number of medical device companies.

“The reality is the EU is putting jobs in Ireland, the people who need to use the medical devices and hospitals at risk. We cannot allow this to happen.

“It’s got to a point where a lot of start-up companies are now looking for approval from the US Food and Drug Administration (FDA) as it is a much quicker process.”

Senator Burke has called on the government to hold urgent talks with the European Commissioner for Health and Food Safety, Stella Kyriakides.

“The root cause of the backlog or hold-ups needs to be determined. It also needs to be established why approval rates are as low as one in four.

“It is unacceptable that any multinational providing jobs in Mayo should be left facing such challenging circumstances which, in turn, is impinging on the level of medical care,” he added.