“Substance-Based Medical Devices: Regulatory Challenges and Prospects”, a new TOPRA article by AESGP

Substance-based medical devices comprise a diverse group of products that are regulated under the Medical Devices Regulation 2017/745 (MDR). They include products that are commonly used as self-care options for the treatment of colds, skin irritations, abdominal pain or other minor ailments, usually available over-the-counter without the involvement of a healthcare professional. Examples of substance-based medical devices include saltwater nasal sprays, lubricant eye drops, dermal creams or gels, etc.

In a new article published in The Regulatory Rapporteur Vol. 19, No. 1, January 2022*, AESGP explores the challenges and uncertainties governing the consistent and pragmatic implementation of the MDR with regards to substance-based medical devices products. It gives an overview of the most prominent changes introduced under the MDR for substance-based medical devices regarding classification and safety aspects; as well as the relevant criteria for the demarcation between substance-based medical devices and medicinal products.

Classification and interpretations challenges

Applicable since 26 May 2021, the new Medical Devices Regulation (MDR) has introduced extensive changes to the regulatory framework governing medical devices that also impact the marketing of substance-based medical devices in the European Union.

While the MDR largely follows the same basic regulatory requirements as the previous Directives, more stringent and additional requirements have been introduced for substance-based medical devices regarding their risk-based classification. For instance, under the new classification Rule 21 of the MDR, many substance-based medical devices are now typically ‘up-classified’, i.e., they are classified in a higher risk category than they were previously. As a result, many manufacturers of those ‘up-classified’ devices will now need the intervention of a Notified Body to place their products on the market.

The implementation of the MDR also proves to be challenging due to different interpretations within some classification rules. The AESGP article thoroughly looks at the challenges implied by the new classification rules architecture and their implications for substance-based medical devices.

Borderline products: substance-based medical device or medicinal product?

Given that the form and route of administration of substance-based medical devices are similar to medicinal products, there are often borderline cases where it is not immediately clear whether a particular product meets the definition of either a medical device or a medicinal product, and therefore should fall under the Medicinal Products Directive (MPD) or the Medical Devices Regulation (MDR). These so-called “borderline products” require a detailed assessment to ensure that they are correctly qualified in terms of product category.

The AESGP article looks at the criteria used to determine whether a product must qualify as a medicinal product or as a substance-based medical device. It notably discusses the importance of the principal mode of action performed by the product to achieve the intended medical purpose, and the decisive role played by the definition and interpretation of “pharmacological, immunological or metabolic (PIM) means” in determining if a product composed of substances or a combination of substances should be qualified as a medical device or a medicinal product.


Read the full article in The Regulatory Rapporteur January 2022*, available on the TOPRA website.

* The article is not in open access and is exclusively available for TOPRA members. Please contact TOPRA for more information.

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