What is happening in the development initiative: Information on clinical studies on medical devices

Karin Skoglund has been the project manager for the development initiative Information on clinical studies on medical devices. In the interview below, she tells about results of the project and what happens next.

Why was there a need for a development initiative around information on clinical studies on medical devices?

The prestudy that was completed in 2017 showed that there is a need for general information about medical devices and what applies when you want to do clinical studies. Despite the fact that many clinical studies with medical devices are made, that it is a large sector and that much indicates that the number of licensed studies will increase, medical technology is often a little bit sidelined in comparison with clinical studies on medicinal products. The goal of the development initiative has been to develop basic and quality-assured information, both about medical device studies that require permission from the Medical Products Agency and those that do not.

What was the result of the initiative?

In early January, we supplemented the existing pages Clinical studies - step by step at www.kliniskastudier.se with more information about medical devices studies. At each step of the study process, there is now quality-assured and neutral information on what applies to medical devices. We have also developed a page on medical devices where, for example, one can read about CE marking and products manufactured by himself. The information has been reviewed by all regional nodes in Clinical Studies Sweden and representatives from innovation supporting infrastructures but also by the Medical Products Agency, the Pharmacy Association, MEDEA and Swedish Medtech.

Is there more to be done in order to facilitate the implementation of clinical studies on medical devices?

Yes it is. This initiative was an important prerequisite for continued work because we now have a good and easily accessible basic information. But the work does not end with this, now there are other challenges for the nodes to take hold of. We also need to work more together with the various parts of the innovation support around the country and there is a great need for courses and training in the medical device field. Some ideas about continued initiatives exist and we hope to have the opportunity to work on these issues.

Picture, from left to right: Sara Aspengren (Swedish Research Council), Helena Fenger-Krog (Karolinska Trial Alliance) and Karin Skoglund (Forum Southeast). Anette Fält (Forum South) and Anna Sandberg Franzén (Swedish Research Council) have also been part of the project.

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