MDR Emergency Kit: the fastest solution for Economic Operators of Medical Devices

Have you thought about how to apply the MDR (EU) 2017/745? The limitations caused by the COVID-19 emergency do not allow you to keep all your appointments with your counsellor? Do you want to save time and costs?

Thema experts propose a fast and effective solution: MDR Emergency Kit, a sort of “S.O.S. toolbox” in digital format to adapt quickly to the restrictive provisions of the MDR (EU) 2017/745.

Templates and standard technical documents available to the customer

  • Standard basic template of the most important documents (QTA; PRRC letter);
  • Technical Documentation template (technical file) with instructions for completion;
  • Basic Quality System procedures;

Four MDR Emergency Kit versions according to specific needs

1. MANUFACTURER– MDR Emergency Kit

  • Template delegation letter Person Responsible for Regulatory Compliance (PRRC);
  • Template Technical Documentation (TD MDR);
  • Template Post-Market Surveillance (PMS) Procedures, Vigilance, RA Communications;
  • Template Information Note to Distributor;
  • Quality Technical Agreement (QTA) Manufacturer/Distributor EU.


  • Template delegation letter Person Responsible for Regulatory Compliance PRRC (different from that of the Manufacturer);
  • Post-Market Surveillance (PMS) procedures, Vigilance, Regulatory Authorities (RA) Communication template;
  • Quality Technical Agreement (QTA) Manufacturer/Authorised Representative only in English.

3. IMPORTER – MDR Emergency Kit

  • Template Non-Conformity procedures, CAPA, PMS, RA Communication, final MD acceptance Controls;
  • Template Acceptance Controls form.

4. DISTRIBUTOR – MDR Emergency Kit

  • Template Non-Conformity procedures, CAPA, Post-Market Surveillance, Regulatory Authorities (RA) and Manufacturer Communications, final Medical Devices Acceptance Controls;
  • Template Acceptance Controls form.

The kit is available in Italian and English.


  • time saving, from a basis developed by Thema experts;
  • customize, adapting standard content to your own reality;
  • saving consultancy costs, if not necessary.

Additional service

Do you need qualified support? Do you need clarification? Thema experts remain themselves available for consulting services, even remotely.

Contact us and receive your MDR Emergency Kit by e-mail!
Thema Staff: t. 0542 643496 /