New MDR and IVDR checklists for PMS and Declaration of Conformity

During the past years, mdi Europa has provided a number of templates and checklists that may be useful for the transition of the Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation (2017/745, MDR and 2017/746, IVDR).

Recently, mdi Europa has set up new checklists on the following topics:

  • Declaration of Conformity
  • Post Market Surveillance (PMS) Plan 
  • Periodic Safety Update Report (PSUR)

Preliminary versions may be reviewed in our Supportive Information section (use link below) and are available for free for our clients. Should you be interested in joining mdi Europa and receiving a copy, please let us know and we will be happy to initiate a cooperation.

Supportive Information Section MDR/IVDR