Help! How do I give my medical device a CE mark?

The 10 most important steps to get approval for the European market.

The VDE CE roadmap

The German technical-scientific association VDE has published a CE roadmap for medical devices.

Every time a medical device is developed, the question comes up at some point which regulatory requirements must be fulfilled. If the new medical device is to be marketed in Europe, it requires a CE marking, i.e., the requirements of the European Medical Device Regulation (MDR) apply.

VDE is repeatedly asked 2 questions at this point:

• What requirements must a product fulfil in detail?
• What does it cost to implement these requirements?

A “quick answer” to these important questions is not possible in most cases. The product-specific requirements differ too much from one medical device to another. In addition, there are differences between the companies and the processes, experience and competences available there.

For this reason, VDE has developed the “CE Roadmap”. The roadmap allows a precise statement of the regulatory requirements for a particular product. This requirement profile is supplemented by a corresponding cost planning for implementation and approval. In addition, the roadmap gives practical recommendations on the market access of a medical device, on processing periods or also on the cooperation with Notified Bodies.

In this article, VDE presents the process of CE road mapping and the benefits for manufacturers of medical devices.