Last updates Jan 2, 2023
Commissioner Stella Kyriakides presented a new proposed amendment to the Medical Devices Regulation, to extend the deadline for recertification during the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) meeting on 9 December. Multiple stakeholders including BioMed Alliance, industry stakeholders and other health stakeholders have repeatedly highlighted that numerous devices are no longer available or at risk of being withdrawn from the market with subsequent consequences for patient care.
The amendment will be officially be proposed for approval next year, and will suggest to extend the deadline for recertification from 2024 to 2027 for high-risk devices and to 2028 for medium and low risk devices.
BioMed Alliance recently called for solutions including a delay of the aforementioned deadline in a press release. Clinicians are already experiencing that essential devices are no longer available due to various consequences, which should be addressed as soon as possible. The deadline will give regulators more time to address issues in the MDR implementation (including notified body capacity and the need for a special framework for orphan and paediatric devices) and provide manufacturers with an extended period to ensure their devices are recertified under MDR.