New version Investigational Medical Device Dossier (IMDD) template available
A new version of the Investigational Medical Device Dossier (IMDD) template is available. This version is an update of the previous version from September 2019 and is in line with the requirements of the EU Medical Devices Regulation (MDR).
The changes mainly concern certain texts about in-house medical devices, requirements that are only mandatory for medical devices with the intention of being marketed and processes for re-using medical devices. A number of textual adjustments have also been made for clarification.