en
Dictionary:

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

The purpose is 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 is expected within the next few years, due to factors such as changed regulatory requirements in the new EU regulations. Already, an increase in the number of requests has been noted at some of the regional nodes.

Background

The development initiative is 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 is one of these.

Goals and implementation

The development initiative shall 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 shall be defined. In addition to serving as a competence bank at the nodes, the working group’s tasks shall 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 will be 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 is expected to be completed in Q2 2020.