Handout

Since May 26, 2021, the requirements of the MDR include further product manufacturers and users. In this webinar, we highlight the requirements for so-called PRODUCTS WITHOUT MEDICAL USE.

These must comply with the basic safety and performance requirements for "classic" medical devices. For example, the risk must be evaluated in advance to ensure that the high level of protection for the health and safety of users required by law is maintained. In addition, their clinical benefit must be demonstrated and the clinical evaluation must be based on relevant safety data. These are, for example, data from surveillance and clinical follow-up after the products have been placed on the market. The clinical trials may only be waived in exceptional cases.

An example of this is "fashion" contact lenses, which have no relevance whatsoever to improving eyesight, but are used, for example, to change or intensify eye color. They therefore lack a therapeutic or diagnostic purpose. At the same time, they resemble genuine medical devices, particularly with regard to the potential risks they pose to the user. This is because the wearers of these lenses expect that they can be safely inserted into the eye. It is the same with other products, for example devices for liposuction, tattoo or hair removal.

The Article 1 paragraph (2) of MDR 2017/745 clarifies the validity of the requirements for devices without a medical purpose. The entire list is provided in Annex XVI of the new MDR.

You will learn what changes in regulatory requirements must be met for your "medical device without a medical purpose" in order to bring a product to market or keep it in the market. There will be an opportunity to ask questions during the webinajkr.

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