Content Technical Documentation

What documents you need

The list of documents you need depends on:

  • the country in which you want to market your medical device
  • the type of device (e.g., medical device versus in vitro diagnostic device)
  • the class of the product (e.g. I, IIa, IIb, III)
  • the product category
  • the selected technologies and materials

Typically, technical documentation includes the following documents or files:

  • Verification and validation plans and results. This includes electrical safety, EMC, and biological safety testing.
  • Clinical evaluation
  • Regulatory documents such as an MDR checklist, declaration of conformity, list of applied standards, justification for classification of the product.