Understanding Borderline Products
Borderline products are those that do not clearly fall under either Regulation EU 2017/745 on medical devices (MDR) or Directive 2001/83/EC on the Community code relating to medicinal products for human use (MPD). A product must meet the definition of a medical device (Article 2(1) MDR) and must also not be excluded from the scope (Article 1(6) MDR) to be classified under the MDR.
As a general rule, a product is regulated either by the MDR or by the MPD, but not both. However, for products that exhibit characteristics of both medicinal products and medical devices, cross-references are made to specific provisions of the other regulation.
General definitions and examples of medical devices and medicinal products can be found in the MDCG 2022-5 Guidance. Additionally, the guidance contains relevant definitions and examples of herbal products, substances used in devices, and combinations of medical devices and medicinal products.
Further Resources
For more information, visit the following link:
MDGC 2022-5 Guidance on Borderline Products - https://health.ec.europa.eu/latest-updates/mdcg-2022-5-guidance-borderline-between-medical-devices-and-medicinal-products-under-regulation-eu-2022-04-26_en