A group representing Ireland’s medical device industry has warned the government that implementation of the new EU rules is under-stretched.
he EU Medical Device Regulation (MDR) came into force in May last year and introduced stricter safety regulations for medical devices.
Device manufacturers must ensure that new and existing products are certified under the updated rules.
In a letter to Health Secretary Stephen Donnelly, the Irish Medtech Association, which is part of Ibec, said “urgent action” was needed at European level to prevent shortages of medical equipment.
The MDR requires devices to be certified by organizations known as Notified Bodies, with May 2024 being the deadline for all devices on the market.
However, the Ibec Group said there is a lack of notified bodies in Europe, which are notified under the MDR, meaning a lack of capacity to verify the devices’ compliance.
“[The] Manufacturers’ ability to bring existing and new medical devices to market is seriously threatened by long, unpredictable conformity assessment deadlines for notified bodies and slow progress in introducing the essential elements of the new regulatory regime,” the letter reads .
It added that “time is almost up” for companies to complete the certification process for certain devices. There are 30 notified bodies under the Regulations including the National Standards Authority of Ireland.
A spokesman for the Ministry of Health said the implementation of the MDR and the certification of devices “has not been without challenges”.
“Ireland is actively participating in the ongoing work at EU level to identify harmonized solutions to the challenges to ensure that the new regulatory regime is effective in practice and achieves its objectives.”
https://www.independent.ie/business/irish/medtech-firms-warn-government-of-urgent-need-for-action-on-eu-certification-process-41827314.html Medtech companies are warning the government of the urgent need for action in the EU certification process