Checklist for GSPR compliance
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 once filled out establishes the objective evidence for the MDR compliance. In addition, it still provides the same for the MDD compliance.
The 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.”