Establishment of a national working group for clinical studies on medical devices

The purpose was to create preconditions for Clinical Studies Sweden to meet the increased demand for support in the implementation of clinical studies on medical devices. The increase was expected within the next few years, due to factors such as changed regulatory requirements in the new EU regulations. There were already an increase in the number of requests at some of the regional nodes.


The development initiative was based on a pilot study conducted within the framework for Clinical Studies Sweden’s development initiatives. The pilot study presented four proposals for new support measures, and the establishment of a national working group for clinical studies within medical devices was one of these.

Goals and implementation

The development initiative would produce a proposal for organisation and funding of a national working group tasked with securing competence within medical devices at the regional nodes over a longer time period. Within the framework for the development initiative, the national working group’s tasks should be defined. In addition to serving as a competence bank at the nodes, the working group’s tasks should also include producing quality-assured template documents for clinical studies, advisory material and training courses with medical technology contents. Another important task for the working group was to participate in creating good collaboration with the other support functions working with medical technology issues at local, regional and national level.

Time plan

The project started at the beginning of Q3 2019 and was expected to be completed in Q2 2020.