Infographic to support researchers in planning an investigation in accordance with Article 82 of the Medical Device Regulation

Fimea has published a new infographic to support researchers in planning clinical investigations in accordance with Article 82 of Regulation (EU) 2017/745 on medical devices. 

The infographic describes the special features of clinical investigations conducted under Article 82 and matters that must be considered when planning the investigation. In addition, the infographic contains Investigator’s Checklist for different phases of the study. 

The infographic has been designed especially to support academic and investigator-initiated clinical investigations and investigators can use it to ensure the smooth progress and conformity of the clinical investigation. The infographic and its text in an accessible format can be found on Fimea’s website “Clinical investigations of devices”. The infographic will also be published as versions in Swedish and English.