LONDON - The EU Health Commissioner on Friday proposed delaying the deadline for companies to comply with a new law regulating medical devices from 2024 to as late as 2028, a major change she said is needed to prevent shortages of lifesaving equipment.
The announcement, which confirmed a Reuters report on Thursday, follows an outcry from doctors' associations and trade groups. They warn that without changes to the Medical Devices Regulation law that took effect last year, many crucial devices would soon disappear from the EU market.
The new law has stricter safety criteria than previous rules for tens of thousands of products, from artificial limbs to blood glucose monitors, sold in the bloc and requires all devices to be re-certified.
Commissioner Stella Kyriakides told a meeting of EU Health Ministers that subject to their approval, she would table an amendment in January to change the timelines for compliance with the law.
She proposed to give manufacturers a new deadline of 2027 for certifying high risk products under the new system and a deadline of 2028 for medium and low risk devices. She also suggested removing a "sell-off" date of May 2025 so that products already on the market will not have to be thrown away.
She said she would formally submit the new timeline as an amendment to the law, which she would table at the beginning of next year.
The transition to a new regulatory system for the EU's multibillion euro medical devices industry has been slower than anticipated, Kyriakides acknowledged.
Under the new law, all devices, from implants and prosthetics to blood glucose meters and pacemakers, sold in the EU must be re-certified by May 2024.
An insufficient number of bodies to do the regulatory work, on top of the COVID-19 pandemic and raw material shortages caused by the war in Ukraine, "has put a strain on market readiness", she said.
If the slow pace of certifications continues, thousands of devices currently sold in the EU could see their paperwork lapse by the current deadline, the EU Commission said earlier this week.
The new law aims to better protect patients and consumers after a 2010 scandal in which a French company used regulatory loopholes to sell leaking breast implants at a profit.