Claims Tracking List


This tracking list serves to assess and verify potential claims from different sources during early and late stage development, and acts as a look-up list for verified and/or validated claims for later use in labeling, in documents and marketing communication. This claims tracking list is compliant to the Medical Device Regulation (MDR) 2017/745 and In-Vitro Medical Device Regulation (IVDR) 2017/746, article 7. Here, you can find the tracking list, which is available as:

  • Word file format,
  • with form fields,
  • corresponds to the requirements of the MDR 2017/745 and IVDR 2017/746, article 7,

as a download in English.



The Medical Device Regulation (MDR) 2017/745 and the In-Vitro Diagnostics Medical Device Regulation (IVDR) 2017/746 demand in their article 7 that claims related to the Intended Purpose, Safety  and Performance of a medical devices are non-misleading when communicated as text, names, trademarks, pictures and figurative or other signs in respective documents and labeling. Therefore, a claims tracking list to provide a trace to from where a claim has arose to when and where objective evidence has been provided to substantiate the claim is vital. This tracking list can be used to conquer this task.