Manufacturers of medical devices based outside the EU must designate an Authorized Representative (EC-REP) established within the EU in order to meet the CE requirements for placing medical devices on the EU market.
For those manufacturers, the EC-REP plays a pivotal role as their contact person established in the Union. In case of requests from EU authorities, the authorized representative will be contacted and ensure the requests and any information required is provided and handled correctly.

Because of the importance of that role of the authorized representative, the MDR and IVDR have determined in detail the responsibilities of the manufacturer and the authorized representative in their articles 10, 11 and 12. Those need, among others, to be addressed in a mandate contract between the EC-REP and the manufacturer.
Acting as an authorized representative for a manufacturer based outside the EU requires a sound legal, regulatory and technical due diligence, which is in the best interest of the manufacturer and the EC-REP. Further, a close network and partnership with the leading liability insurance providers is a must in order to provide a reliable service that adds value beyond the «Name on the Label».

Medidee Services (Deutschland) GmbH has the competence and credentials required and is ensuring the service of an Authorized Representative for Medical Device Manufacturers based in the USA, UK and Switzerland.


Medidee Services (Deutschland) GmbH helps set-up and execute the EC-REP mandate:

  • Review and ensure product compliance with the essential requirements set out in the applicable European Directive (i.e. 93/42EEC, 90/385EEC, 98/79EC) or 2017/745 MDR and 2017/746 IVDR Regulations
  • Develop and implement the mandate contract fixing rules and interfaces compliant with the EU Regulations.
  • Provide support to clarify insurance requirements, provide adequate expert contacts with leading liability insurance companies in the life-science field
  • Provide you, with a European contact, details to be placed on your device labels, packaging, and Instructions for Use, thus acting on your behalf as the main contact for all European Competent Authorities.
  • Support you to implement the necessary adaptations to your packaging, labeling and IFU to comply with national requirements
  • Register your device with the national Competent Authorities before being placed on the market
  • Maintain a current copy of your Technical Documentation available for inspection by the European Competent Authorities and protect the confidentiality of your documentation
  • Perform the audits of your subcontractors located within the EU (Suppliers, distributors, etc.)
  • Ensure the communication necessary in case of vigilance, coordinate any Incident resolution or Field Safety Corrective Action with the Competent Authorities, in cooperation with you and your distributors
  • Notify EU Authorities of all major incidents pertaining to products when necessary
  • Follow-up applicable EU regulations for each of the 27 EU member states as well as the 4 European Free Trade Association (EFTA) states, and provide notification of changes and amendments to directives and regulations that would affect individual products