Reuters first reported the news yesterday and confirmed it today. Commissioner Stella Kyriakides proposed a delay for the deadline for companies to comply from 2024 to as late as 2028. According to the report, this comes because of a need to “prevent shortages of lifesaving equipment.”
The report noted that pushback from doctors’ associations and trade groups presented warnings around EU MDR implementation. The regulations came into effect in 2021. This change replaced the EU Medical Device Directive (MDD) with more stringent requirements on the companies that perform the audits for each device.
The change affects not only devices that are new to the EU market but those that entered the market under MDD. Companies must re-certify them under MDR so they remain available for sale — a costly and time-consuming process.
Kyriakides reportedly told EU health ministers that, with their approval, she plans to put forth an amendment in January. This would change the timelines for compliance. Her proposal would offer manufacturers a deadline of 2027 to certify high-risk products. It features a 2028 deadline for medium and low-risk devices, Reuters said. Additionally, she suggested the removal of a sell-off date of May 2025 so products currently on the market need not be thrown out.