CLASSIFY My Device tells you the European classification of your medical device. The app uses simple step by step questions and answers to work through the Annex IX rules of the European Medical Device Directives and provide a final classification estimate for your device. You can go back and revisit any question at any stage.
Context sensitive help provides instant references to the definitions and interpretation drawn from the Directives and European guidance.
You get a written record of the applicable rules and final classification both on screen and (optionally) emailed straight to your inbox.
Understanding the correct classification is an essential first step in figuring out the regulatory requirements for a medical device in Europe. CLASSIFY My Device makes this essential first step easy.