Borderline products
Borderline products are complex healthcare products which generate uncertainty over the applicable regulatory framework.
HumanMedical devicesRegulatory and procedural guidance
Common borderlines are between medicinal products, medical devices, cosmetics, biocidal products, herbal medicines and food supplements.
National competent authorities classify borderline products either as medicinal products or, for example, as medical devices on a case-by-case basis. This determines the applicable regulatory framework.
Applicants who are unclear on the correct classification of their product should consult a national competent authority and provide information on the product's composition and constituents, a scientific explanation of the mode of action and its intended purpose.
EMA role
The Medical Devices Regulation foresees that the European Commission may consult EMA on products that borderline with medicines.
EMA's Innovation Task Force provides advice to medicine developers on eligibility to EMA procedures relating to the research and development of borderline products. For more information on the Innovation Task Force, see Supporting innovation.
Page update history
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2 March 2026
Page first published; Content has been moved from another webpage as part of a broader content reorganisation