Dr. Lücker - Rechtsanwalt - MP Recht

Conformity assessment

Medical devices can only be marketed and sold on the European market if they have completed the conformity assessment procedures required by law.
But what procedure is appropriate? To which risk class must the device be assigned? Does a notified body or an authority need to be involved and if so to what extent? It is often not easy to find the answers to these or other questions, although these answers are fundamentally important for the entire future life cycle and success of a medical device in the marketplace. We can provide the necessary specialist know-how and experience to find the right answers in order to avoid any potential obstacles in advance.