Stability Testing

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 …

Stability Testing

Stability testing is a critical process that ensures product safety, efficacy, and compliance with regulatory standards in medical devices. Under the Medical Device Regulation (MDR), stability testing takes on heightened importance due to its focus on patient safety and rigorous requirements. This article explores into stability testing, its significance, key components, and best practices for …