Economic Operator Checklist – Authorised Representative (EC REP)


The Medical Device Regulation MDR 2017/745 and the In-Vitro Diagnostics Medical Device Regulation IVDR 2017/746 define requirements for economic operators. In articles 11, 13, and 14, the MDR and IVDR define the specifics for EC REP, Importer, and Distributor, respectively, in order to be compliant with the regulation. The checklist contains:

  • All documents in word file format
  • Requirements per MDR 2017/745 and IVDR 2017/746


The MDR 201/745 and IVDR 2017/746 define requirements for economic operators, such as EC REP, importer, or distributor. The specific checklist defines processes and check points to document compliance with the regulations.