Borderline - Medical Devices
Before a product can be placed on the market, it is important to determine whether it should be regulated as a medical device. This also includes assessing whether the product may qualify as an in vitro diagnostic (IVD) medical device.
If a product has a medical purpose, meaning that it is intended for the treatment or alleviation of a disease or disability (see below), it must be regulated either as a medicinal product or as a medical device. To determine this, the product's primary mode of action must be assessed. If the primary effect is achieved through pharmacological, immunological, or metabolic means, the product must be regulated as a medicinal product. In all other cases, it must be regulated as a medical device. Medical devices generally achieve their intended purpose through a physical or mechanical mode of action.
To determine whether a product has a medical purpose, it is necessary to assess whether it is intended to treat a disease. A distinction must be made between products intended to treat or diagnose actual diseases, symptoms, disorders, or disabilities and products intended solely for wellness purposes. The full definition of a medical device is as follows:
“Any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease.
- Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability.
- Investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state.
- Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations.
and which does not achieve its principal intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its function by such means.”
It is not always easy to determine what is meant by “disease.” Guidance can be found in an indicative list of diseases.
Although the list refers to medicinal products, the same principle applies and the list can therefore also be used when assessing medical devices.
If your product is not a medicinal product and is intended to act on a disease listed there, it is highly likely to qualify as a medical device.
The intended medical purpose of the device must be reflected in the marketing materials. Therefore, products that are not marketed as medicinal products or medical devices must not be advertised as having an effect on diseases.
Additional guidance is available on the European Commission's website under "Borderline and Classification".
Certain products without a medical purpose are also covered by medical device legislation. These are known as Annex XVI products. More information on these products can be found here.
Typical Borderline Cases
The categories below include products that may fall in the borderline field of medical devices or in vitro diagnostic medical devices. Please find links to the responsible authority of the specific product category: