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…

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,…