Clinical investigations of medical devices (MDR)

Research ethics assessment of clinical investigations of medical devices regulated by MDR

The EU Medical Device Regulation (Regulation (EU) 2017/745, MDR) entered into force on 26 May 2021. Applications for clinical investigations of medical devices covered by the MDR are assessed in accordance with the Regulation and related legislation.

On behalf of the research ethics authorities, REK KULMU conducts a research ethics assessment of applications covered by the MDR.

MDR resource pages:

• • The Norwegian Medical Products Agency’s (NOMA (DMP) website, including an introduction to clinical investigations of medical devices and a regulatory guide
  • Guidance documents issued by the Medical Device Coordination Group (MDCG)
  • Regulatory guide for clinical investigations under the MDR (in Norwegian only)

Updated 17.09.2026