The product description of your medical device may need to be updated and adapted according to the new MDR regulation. A product description and specification include the product name and intended use, as well as the ID number and risk class . Furthermore, the product description contains parts of the intended purpose. This includes a description of the intended patient population and the principle of operation of the product. Finally, the physical and technical specifications, such as raw materials, dimensions, and performance characteristics, must be provided.
If an older generation already exists for the medical device, the “novel features” of the new product and a reference to its predecessor must be provided. Likewise, comparative products available in the EU or international market must be listed separately.
More information on this topic can be found in Annex II of the MDR in our download area.