Modifications to Legacy Devices: MDR Guide

Legacy Devices: Guidance on significant changes according to the EU Medical Device Regulation (MDR) 2017/745 Article 120, paragraph 3, of the EU Medical Devices Regulation (MDR) 2017/745, amended by the latest Regulation (EU) 2023/607, states that devices that remain compliant with the AIMDD or MDD can be placed on the market until December 31, 2027,…

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…