CEEASY: A guiding tool throughout the medical devices CE marking process. Case study: MiWEndo

Abstract

The medical device sector has been growing for the last years and it is expected to keep growing. As CE marking is necessary to sell products in Europe, everyday more entrepreneurs need to learn how the CE marking process works. Finding information is easy, what is difficult is to identify the information that applies to a specific product, which ends up in manufacturers referring to consultant companies (which are really expensive). CEEASY has been created from the premise that the CE marking process can be done without a consultant but is cumbersome. CEEASY is a free online tool for novice people in regulation. Different resources (surveys, classifications, guides, templates and samples) have been designed to help users get more device-specific information in each step of the process. With the help of CEEASY entrepreneurs not only will save money but time. The second part of the project is a use case. Here we use all the resources that can be found in CEEASY’s website in a real case, the project MiWEndo developed by BCN MedTech research group. MiWEndo aims to bring to the market a new medical device to improve colonoscopy using microwave imaging. A complete overview of the regulatory path for MiWEndo has been developed. All the steps of the CE marking process that could be realized (according to the actual state of their project) have been realized, and for the future steps recommendations on how to resolve them are provided.