Under the MDR 2017/745, medical devices are classified into different classes based on their intended use and potential risks to patients. The MDR also includes additional requirements for certain devices, including borderline products.
Borderline products are those that have characteristics of both medical devices and other products such as:
–      Borderline between medical devices and medicinal products,
–      Borderline between medical devices and substances of human origin
–      Borderline between medical devices and cosmetic products
–      Borderline between medical devices and personal protective equipment

It’s important to understand the mode of action of the product to truly determine the regulatory framework. Incorrectly classifying a product can result in huge financial loss.

In the case of borderline products, careful assessment is necessary to determine whether they meet the definition of a medical device and to qualify them appropriately. This assessment may involve consultation with regulatory authorities and may require expert opinion to make a determination.