MedTech firms warn govt of urgent need for action on EU certification process

A group representing Ireland’s medical device industry warned the Government that the implementation of new EU rules is running at under capacity.

The EU’s Medical Device Regulation (MDR) came into application in May of last year and introduced stricter safety rules for medical devices.

It requires device manufacturers to ensure new and existing products are certified under the updated rules.

In a letter to Health Minister Stephen Donnelly, the Irish MedTech Association, part of Ibec, said “urgent action” is needed on a European level to prevent shortages of medical devices.

The MDR requires devices to be certified by organisations called notified bodies, with May 2024 being the deadline for all existing devices on the market.

However, the Ibec group said there is a shortage of notified bodies around Europe that are designated under MDR, meaning a shortfall in capacity for checking devices’ compliance.

“[The] manufacturers’ ability to place existing and new medical devices on the market is seriously jeopardised by the lengthy, unpredictable conformity assessment timelines for notified bodies and the slow progress in putting the essential elements of the new regulatory system in place,” the letter said.

It added that “time has nearly run out” for companies to complete the certification process on certain devices. There are 30 notified bodies designated under the regulation, including the National Standards Authority of Ireland.

A spokesman for the Department of Health said the implementation of the MDR and certifying devices has “not been without challenge”.

“Ireland is actively participating in work ongoing at EU level in identifying harmonised solutions to the challenges faced to ensure the new regulatory system is effective in practice and delivers on its objectives.”