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.