GFI Extends MDR Compliance for Legacy Devices until 2028

MDR Transition Period Extension: FarmaImpresa Ensures Compliance for its Legacy Devices until 2028 The MDR (Medical Device Regulation), which came into force in May 2017 and has been applicable since May 2021, aims to create a robust and transparent regulatory framework for medical devices in Europe, ensuring safety and promoting innovation. However, because of concerns…

European Commission releases Q&A in MDR area

A question and answer document has been published by the European Commission, the purpose of which is to facilitate the application of Regulation (EU) 2023/607 The main objective of the European Medical Device Regulation (MDR) 2017/745 is to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensuring a high level of…