Regulatory guide for electronics in medtech innovations

Purpose and goal:

All set project goals were met and further system effects can be seen through increased dialogue and knowledge dissemination between relevant actors - both within but above all also outside the project. Interest in regulatory issues surrounding biomedical engineering has increased, especially interesting in the public sector. In the long term, this project will contribute to both shortening the time from idea to patient benefit but also safer self-made products.

Expected results and effects:

In the long term, the project results will contribute to more competitive Swedish medical technology companies with better conditions for growth, safer products for patients regardless of whether they are provided by companies or the public sector. It is also hoped that, in the long term, the results of subsequent dialogues can contribute to harmonized interpretations of the regulations surrounding the medical technology area.

Approach and implementation:

The material has been developed via around 40 workshops where roughly 20 expert organizations participated with over 40 individuals to develop the content. The subject matter has then been packaged with the help of a writer into the finished manual´s format of 7 chapters. Quality review of the material has taken place with the help of an external expert group. Cooperation with relevant authorities has also been carried out as well as relevant project within Medtech4Health.