The EU health commissioner has proposed extending the deadline for companies to comply with a new law regulating medical devices from 2024 to 2028 – a key change she says is needed to prevent shortages of life-saving equipment.
The announcement follows an outcry from medical associations and trade groups. They warn that without changes to the Medical Devices Regulation, which came into force last year, many important devices would soon disappear from the EU market.
The new law has stricter safety criteria than previous regulations for tens of thousands of products, from artificial limbs to blood glucose meters sold by the block, and requires all devices to be re-certified.
Commissioner Stella Kyriakides told a meeting of EU health ministers that she would table an amendment to change the deadlines for compliance with the law, subject to her approval in January.
She proposed giving manufacturers a new deadline of 2027 for certifying high-risk devices under the new scheme and a deadline of 2028 for medium- and low-risk devices. She also suggested removing a May 2025 “sell-out date” so that products already on the market don’t have to be thrown away.
She said she will officially submit the new schedule as an amendment to the law, which she will submit early next year.
The transition to a new regulatory regime for the EU’s multi-billion dollar medical device industry has been slower than expected.
Under the new law, all devices sold in the EU, from implants and prostheses to blood glucose meters and pacemakers, must be re-certified by May 2024.
An insufficient number of jobs to do the regulatory work, added to the Covid-19 pandemic and raw material shortages caused by the war in Ukraine, “has weighed on market maturity,” she said.
If the slow pace of certifications continues, thousands of devices currently sold in the EU could see their papers expire by the current deadline.
https://www.independent.ie/business/world/medical-device-law-delayed-by-european-union-due-to-concerns-over-shortages-42209204.html The Medical Devices Act is being delayed by the European Union over concerns about bottlenecks