Certainty and challenges due to the new EU Medical Device Regulation
This is based on the main effect of the product. In contrast to medicinal products that act pharmacologically, immunologically or metabolically, the main effect of medical devices is achieved primarily by physical means. If both medical device and medicinal product are combined in one product, the corresponding principal effect is decisive for the classification of the product.
Substance-based medical devices are not initially perceived by patients as medical devices, as they are similar to a medicinal product in terms of their form of administration and appearance. An example of this is the tablet. When is a tablet a medicinal product and when is it a substance-based medical device? This is also based on the main effect of the product. For example, if the active ingredient in the tablet creates a physical barrier over the mucous membranes so that irritations are reduced, the tablet may be a material medical device. If, on the other hand, it causes a reduction in bacterial growth, for example through an antibiotic effect, the tablet is a medicinal product.
Examples of substance-based medical devices:
Solid, semi-solid and liquid preparations, such as:
which have no pharmacological effect on humans, but are used to detect and treat diseases.
Substance-based medical devices have not yet been duly recognised. The EU Commission had even considered removing them completely from the medical device law. In fact, the products are very relevant, especially in terms of health economics. Many of these products are over-the-counter and suitable for self-medication. They relieve the health care system extremely because patients try to treat themselves at their own expense before going to the doctor.
The MDR is a European regulation that does not have to be transposed into national law and is directly applicable in the member states of the European Union. The MDR replaces the two EU directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices. The introduction of MDR is intended, among other things, to harmonize European medical device law, provide legal certainty for manufacturers of medical devices and facilitate access to the European market for new medical devices.
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