The requirements of the MDR became applicable to all medical devices sold in the EU as of 26 May 2021. However, the implementation of certain MDR provisions will be extended until as late as May 2024 for medical devices that were previously approved under the Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD).
The complexity in developing new and advance medical devices, combined with the rigorous requirements embodied in the EU’s MDR, are like to make the regulatory approval process challenging for many device manufacturers. Even manufacturers of medical devices that were previously approved under the MDD or the AIMDD are not exempt from the MDRs requirements, and legacy devices still being sold on the market must be recertified in accordance with the MDR’s provisions.
The infographic below details the key changes and latest timeline of the MDR in a concise manner.