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.
VDE (Verband der Elektrotechnik, Elektronik und Informationstechnik) is one of Europe’s largest technical-scientific associations with 36,000 members, including 1,300 corporate and institutional members and 8,000 students.
VDE has been supporting the medical device industry for many years. During this time, the challenges for all those involved have constantly increased.