With our seleon app, you can quickly check the classification of your medical devices in accordance with the Medical Device Regulation (MDR).
The MDR has been in force since 2017 and regulates the directives on medical devices (93/42/EEC, MDD) and active implantable medical devices (90/385/EEC, AIMDD) and is legally binding as a regulation. The requirements for your product may have changed as a result of this change.
Answer the following questions and the app will show you the corresponding classification according to the current regulation. If you would like to receive the detailed questions with your answers, you can enter your e-mail address so that a report can be sent to you afterwards. seleon is a leading service partner for Medical Technology companies in Central Europe, focusing on the areas of development, consulting and production. We develop first-class medical products on the basis of a pronounced innovative strength and technological ambition, thus providing sustainable added value for our national and international customers.