Research ethics assessment of clinical investigations of medical devices (MDR)
The EU regulations for medical devices (Medical Device Regulation 2017/745), entered into force 26. May 2021. Applications for clinical investigations studies (hereafter called “studies”) that fall within the scope of MDR are now processed according to the MDR and associated regulations.
.On behalf of the ethics authorities, REK KULMU carries out a research ethics assessment of applications that fall within the scope of MDR.
Resource pages MDR:
- NoMA’s website
- Guidance documents from MDCG; medical device coordination group
- Regulatory guide for clinical trials according to the MDR (only available in Norwegian)
