JUNE Medical welcomes the new amending Regulation as it ensures market access to safe medical devices while providing additional time to manufacturers and Notified Bodies to complete the transition of their devices to the MDR. The additional time also provides opportunities to help more manufacturers bring their innovative devices to the EU market.
JUNE Medical CEO Angela Spang comments: “While we are supporting the amendments, we are not changing our plans: we are continuing our MDR application as we are mid-process with our notified body BSI, and look forward to certification later this year.
More on MDR:
The European Medical Device Regulation (MDR) replaced the MDD and the AIMDD and entered into force on 25 May 2017 with 26 May 2021 as date of application.
To access legacy devices’ extended timelines, by May 2024 manufacturers must have implemented an MDR compliant QMS and have applied to a Notified Body for a Conformity Assessment. By September 2024, the Notified Body and the manufacturer must have signed a formal written agreement. Depending on legacy devices classification, MDR transition deadline is May 2026 for Class III custom-made implantable devices, December 2027 for Class III and Class IIb implantable devices (non-WET) and December 2028 for other Class IIb, Class IIa, Class Is and class Im devices. On the same date, up-classified legacy devices (whose Declaration of Conformity was signed by 26 May 2021) now requiring Notified Body involvement must be MDR certified. All legacy devices must be MDR compliant by the end of December 2028.
The sell-off period for medical devices already placed on the market under MDD and AIMDD has been removed. These devices can be made further available on the market without legal time restrictions.