A “borderline product” is a product whose classification as a pure medical device (MD) is not clear or not possible. BEO BERLIN is particularly familiar with the distinction between MDs and in-vitro diagnostic products (IVDs) and non-MDs (e.g. wellness or sports products). As a general rule, the specific classification of a borderline product must be made on a case-by-case basis. In a manual and a guideline, the European bodies specify the framework conditions for the classification of borderline products.
Relevance
The classification of a product as „borderline“ is important for manufacturers right from the start, as the regulatory requirements change depending on the classification. As the classification of borderline products is decided on a case-by-case basis, it may be advisable to seek external expertise. Here you will find an incomplete list of markers that can identify a product as a borderline product.
Characteristics of borderline products
Multiple functionality – Combines features of both medical devices and other products such as wellness devices or IVDs as well as cosmetic products or protective equipment.
Primary mode of action – The primary mechanism of action of medical devices must not be pharmacological, metabolic or immunological and must not act within the patient’s body.
Assessment of borderline products
The final assessment of borderline products is the responsibility of the competent authorities and notified bodies. The classification is mainly based on three dimensions defined in the MDR:
- Specific medical purpose of the device as stated in Article 2(1) MDR, first paragraph: The main reason for using the Device.
- Intended main effect of the device as defined in Article 2(1) MDR, second subparagraph: The wanted consequence of the use of the device.
- Main mode of action of the device as described in Article 1(6) MDR: Refers to the primary mechanism by which the medical device exerts its main effect.
These three dimensions are the main criteria used to determine the borderline status of a device. It is important to note that the actual evaluation of a product is a complex process that is carried out by experts. This article does not claim to be exhaustive on the question of evaluation criteria for borderline products.
