Proposal of EUMDR transition extension
Great news for Medtech companies!! Yes. During the December 9th, 2022 session of the Employment, Social policy, Health and Consumer Council (EPSCO) meeting held in Brussels, Belgium. Stella Kyiakides, the European health commissioner announced the postponement of MDR transition deadlines to 2027 for class III and IIb devices and 2028 for lower risk devices such as class I and class IIa devices.
Initially, when MDR was published in 2017, full transition from MDD and AIMD to MDR was planned to complete by May 26th 2020. However, due to COVID -19, it was postponed by a year (May 26 2021). Now the transition date has been postponed again.
At the meeting, more than 20 EU member state’s health ministers raised concerns over the shortage of medical devices supply in their countries due to the current situation, which would affect the patient’s safety and health.
Stella Kyiakides stated that “The transition to the new rules has been slower than we anticipated.” Also she added “The pandemic, shortages of raw materials caused by the Russian invasion against Ukraine and low notified body capacity has put a strain on market readiness.”
There has been progress in increasing the number of notified bodies designated for medical devices from 30 in June to 36, and the number of notified bodies under IVDR stands at 8.
The following points were included in the announcement. They are:
– Extension of transition deadline based on the risk class of medical devices
– Extension would apply to devices which are already deemed safe and have not undergone any significant change. Also, the manufacturer have already initiated the certification process under MDR
– Removal of “sell-off” date of May 25, 2025 under both MDR and IVDR to prevent medical devices which are already deemed safe on the market from being discarded
According to MedTech Europe, around 23,000 certificates issued under MDD and 1500 under IVDD are yet to transition to MDR and IVDR respectively.
The commission is expected to issue draft proposal guidance in the early 2023 to highlight the points mentioned above.
