Intended purpose at a glance

The "intended purpose" describes the manufacturers understanding of "WHAT IS THE PRODUCT TO BE USED FOR", which includes the:

  • "Intended use" describing HOW TO USE the product
  • "intended user" describing WHO IS TO USE the product
    • this may be either the patient or the user
  • "environment" describing WHERE or under WHICH CONDITIONS to use the product
  • "indications" explaining WHAT are the medical preconditions for the person using the product, such as diseases or state of health
  • "Medical claims" describing the medical effects the use of the device shall lead to
  • "Contraindication" describing the medical precondition which disqualify for the use of the device.