Privacy settings

We use cookies on our website. Some of them are essential, while others help us improve this website and your experience.

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.