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Is it a drug or a device? A useful guidance document on borderline products available

The Medical Device Coordination Group (MDCG) has in April provided guidance on how to better identify the borderline between a medical device and a drug. The guidance document provides for example definitions related to medical devices, drugs and accessories. The guidance includes separate sections for herbal products, substance-based devices and drug-device combinations.

Identification of the applicable legislation between the Medical Devices Regulation EU 2017/715 (MDR) and the Medicinal Products Directive 2001/83 (MPD) may be challenging for the borderline products. The applicable legislation is defined by the intended use and the main mode of action of the product.

A product may be classified as a medical device if it achieves its main purpose by other than pharmacological, immunological or metabolic means. Usually, the mode of action of the devices is achieved by physical means. Examples of medical devices include dental fillings, wound dressings, blood bags and absorbable sutures, whereas accessories include for example contact lens care products and ultrasonic gels.

The guidance document also provides examples of medical devices falling under the rule 21 of MDR Annex VIII: salt water, moisturizing eye drops for nasal or throat sprays and oral cough treatments.

Read more guidance and examples in this guidance document: https://ec.europa.eu/health/system/files/2022-04/mdcg_2022-5_en_0.pdf