IVDR Emergency Kit

ivdr emergency kit eng

IVDR Emergency Kit: the fastest solution to respond to the main obligations of the IVDR (EU) 2017/746.

Experts Thema projected a solution to allow Economic Operators in the IVD sector to quickly and independently align with the main provisions of the IVDR (EU) 2017/746, saving time and costs.

IVDR (UE) Emergency Kit is a sort of “toolbox” in digital format that collects the essential technical tools, the operational base to meet the main IVDR obligations.

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;
  • fundamental Quality System procedures.
Four IVDR Emergency Kit versions according to specific needs
  1. MANUFACTURER – IVDR Emergency Kit
  • proxy letter template Person Responsible for Regulatory Compliance (PRRC);
  • technical Documentation template (DT IVDR);
  • post-market Surveillance Procedure (PMS) template, Vigilance, Regulatory Authorities (RA) Communications;
  • template Information Note to Distributor;
  • Quality Technical Agreement (QTA) Manufacturer/Distributor EU.
  1. AUTHORISED REPRESENTATIVE – IVDR Emergency Kit
  • proxy letter template Person Responsible for Regulatory Compliance PRRC (different from that of the Manufacturer);
  • post-market Surveillance Procedure (PMS), Vigilance, Regulatory Authorities (RA) Communication template;
  • Quality Technical Agreement (QTA) Manufacturer/Authorised Representative only in English.
  1. IMPORTER – IVDR Emergency Kit
  • Non-Conformity procedures, CAPA, PMS, Regulatory Authorities (RA) and Manufacturer Communication, final MD acceptance check template;
  • importer acceptance check form template.
  1. DISTRIBUTOR – IVDR Emergency Kit
  • template Non-Conformity procedures, CAPA, Post-Market Surveillance, Regulatory Authorities (RA) and Manufacturer Communications, final Medical Devices Acceptance Checks;
  • template module Acceptance Controls.

The kit is available in Italian and English.

What are the advantages?
  • time saving, from a basis developed by Thema experts;
  • customize, adapting standard contents to your own reality;
  • save the consultancy costs, if not necessary.
Additional services 

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

Contact us for INFORMATION, COSTS and receive your IVDR Emergency Kit by e-mail!
Thema Staff: t. 0542 643496 / sales@thema-med.com 

Do you want to receive updates on the main regulatory news from around the world?

Fill out the form below and receive Thema newsletters.