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,…

MDR regulations: the technical file

When is a change in a medical technical file considered significant under Art. 120(3)MDR? A Medical Device Manufacturer with a valid certificate issued by a Notified Body under Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD) may place its devices on the market even after May 26, 2021 (date of full implementation of MDR (EU) 2017/745)…