Products for diagnostic purposes can be classified as either medical devices or medicinal products, depending on their nature and use. The classification as a medical device is clear when the product is an instrument or apparatus, such as imaging equipment (e.g., MRI, CT scanners). However, the distinction is more nuanced if product for diagnostic purpose is substance-based.
According to Article 2(1) of the MDR, a medical device does not achieve its principal intended action by pharmacological, immunological, or metabolic means in or on the human body. At the same time, according to the definition of a medicinal product in Article 1(2)(b) of the medicinal products Directive 2001/83/EC, any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis falls under the definition of a medicinal product. This means that the mode of action for diagnostic substances does not determine the regulatory route. Consequently, the key point for determination regulatory status is whether the product meets the definition of diagnosis. ‘Diagnosis’ involves investigating the anatomy, morphology, condition, or functions of the human body—whether physiological or pathological—and interpreting this information to identify possible abnormalities. This process can include visualization, detection, or measurement.
If the intended purpose of the product is to distinguish between healthy and pathological tissue in vivo or ex vivo, it is regarded as diagnosis. Thus, substances such as X-ray contrast media, NMR enhancing agents, and radioactive tracers are classified as medicinal products. However, if the intention is to simply visualise an anatomical structure without the aim to determine possible abnormalities, this would not be considered as diagnosis. Therefore, the following type of products should be considered as medical devices: the substance that is a colorant used to mark the location of a surgical procedure site, markers that are placed or implanted for radiation therapy, the substance that is used to highlight tissues, aiding in distinguishing them during a surgical act without the intention of making a diagnosis, etc.
If products are intended for in vitro diagnosis, they are classified as in vitro diagnostic medical devices under Regulation (EU) 2017/746 (IVDR).
Understanding whether diagnostic products are classified as medical devices or medicinal products is crucial, as it determines the regulatory pathway they must follow, impacting everything from development and testing to market approval and post-market surveillance. At Starodub, we specialize in guiding medical device and medicinal product manufacturers through the complexities of different regulations. For more information, contact us via our Contact page.