Medical device “significant changes” under the EU MDR
In May 2023, the Medical Device Coordination Group (MDCG) issued MDCG 2020-3 Rev.1 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD. These significant changes are changes in design or intended purpose of medical devices. Some of these …