Current challenges and Requirements for Substance-based Devices

In the current European regulatory landscape, it may be challenging to define which directive/regulation applies to substance-based products (i.e., products that achieve their intended purpose by the action of their ingredients). 


Considering the regulatory aspects from the start of development of a product is particularly of prime importance for substance-based devices because such products may be qualified either as medical devices, medicinal products or, in some cases, as cosmetics. Fulfilling the specific regulatory requirements brings the need for well-defined strategies.

Did you know substance-based products may be qualified as medical devices?

The qualification of a substance-based product as a medicinal product or a medical device can be challenging, with several products often being “borderline”. Watch our on-demand webinar to get practical examples of the qualification and risk classification of substance-based products.

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Substance-based devices - eye drops

In an initial step, an assessment of the qualification of the substance-based product is always a necessity. This is done by evaluating the modes of action of the individual ingredients present within the product, considering its intended use. 

At this stage, Medidee’s consultants will provide the initial documentation as needed in form of a classification statement. This document can be used by the manufacturer to confirm the classification of their product to the competent authority. Furthermore, Medidee’s experts will provide support in the whole regulatory pathway. 

Should the product be deemed a medical device, as a substance-based medical device, specific General Safety and Performance Requirements are likely to be applicable, namely GSPR 12.1 and/or 12.2. The team at Medidee will generate the necessary documentation to fulfil these requirements, either by gathering scientific literature or by recommending testing.

Substance-based devices - hand sanitizer

The qualification of a substance-based product as a medicinal product or medical device can be challenging, with several products being “borderline”In some cases, the product may even be qualified as a cosmetic product.

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Medidee’s services supporting the Substance-based Device Industry

From planning to development, up to market release, Medidee proposes the following services:

Contact Medidee to discuss your needs