Major Changes

Articles 120(2) and 120(3) of the Medical Devices Regulation (MDR) 2017/745 state that devices with a valid certificate issued by a notified body under the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC or the Medical Devices Directive (MDD) 93/42/EEC may be placed on the market or put into service after the application date of the MDR by 26 May 2024 at the latest, provided that certain conditions are met.

This requires that no significant changes are made to the design or intended use of the device after the MDR application date. Therefore, it is important for manufacturers and notified bodies to be clear on the significant changes that will be assessed within the scope of Article 120(3) of the MDR.

See MDCG 2020-3 Significant Changes

See NBOG-BPG-2014-3 Significant Changes