Borderline products are those products for which it is not entirely clear whether they fall under the Regulation (EU) 2017/745 on medical devices (MDR) or the Directive 2001/83/EC on the Community code relating to medicinal products for human use (MPD). A product must fulfill the definition of a medical device (Article 2(1) MDR) and must also not be excluded from its scope (Article 1(6) MDR) in order to fall 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 have properties of both medicinal products and medical devices, some cross-references are made within one regime to specific provisions of the other regime.
General definitions and examples of medical device and medicinal product are provided in the MDCG 2022-5 Guidance. Moreover, the relevant definitions and examples of herbal products, substance-based devices and medical device and medicinal product combinations can also be found in the guidance.
Attachment: MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.
MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices