checklist is a great tool for the transition to the MDR with your current MDD compliant products. Are you not tired of the Notified Body answer: “What you have done for the MDD essential requirements (ER) will not be sufficient. There is definitely more for you to do with the MDR GSPR...
This Excel spreadsheet is designed to support manufacturers making the transition from MDD to MDR. It is specifically designed for the area of MDD “essential requirements” vs. MDR “general safety and performance Requirements” Annex I. This checklist
The EU Medical Device Regulation (MDR) replaces the previous Medical Device Directive (MDD), and came into effect 26 May 2021. There are several key differences between the MDD and MDR and we receive questions regularly from manufacturers. Download this free FAQ doc to read this compilation, ...