Information on clinical studies on medical devices
The aim was to complement the website kliniskastudier.se with neutral, quality assured information on all aspects of clinical studies on medical devices. There would also be summarised information on CE marking and what to consider before planning a clinical study.
The development initiative was based on a pre-study conducted within the framework of Clinical Studies Sweden. The pre-study demonstrated a need from industry, researchers and healthcare professionals to, through a neutral source of information, gain access to an overview of all steps in the implementation of a clinical study on medical devices.
Aim and implementation
The focus of the implementation project was to provide quality assured information on how a medical device study should be carried out, both for those who intend to commercialise a product and for those who have an academic perspective. In connection with the CE marking and commercialisation of a medical device, it is particularly important to put the clinical study in context and describe what needs to be done before planning a clinical study involving humans. The information have been published on the website www.kliniskastudier.se.
The project team was working on producing texts regarding clinical studies on medical devices. The texts have been quality controlled in several steps, including using a reference group. The reference group included people from regional nodes, representatives from innovation support activities and relevant authorities.
The project started in Q1 2018 and was expected to be completed by the end of Q4 2018.