Reserach ethics assessment of clinical investigations of in vitro diagnostic medical devices (IVDR)
The EU regulations for in vitro-diagnostic medical devices (In Vitro Diagnostic Medical Device Regulation 2017/746), IVDR entered into force on 26 May 2022.
Applications for performance studies that fall within the scope of IVDR are now processed according to IVDR 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 IVDR.
Until further clarifications from the EU, all performance studies regulated by IVDR article 58(1), 58(2), or 70 must apply for approval by REK KULMU. This includes studies of IVD for companion diagnostics (CDx performance studies) where only leftover samples of biological material are to be used.
For performance studies not regulated by IVDR article 58(1), 58(2), or 70, the general requirements of IVDR article 57 apply. The assessment of performance studies under article 57 will be carried out by the regional RECs according to the Health Research Act. Please be aware that article 57 studies should be submitted in accordance with the application deadlines of the regional RECs. The checkbox for medical devices in the REK application form (section 1.10) should not be selected, but make sure to clearly describe in the application if IVDR article 57 applies.
Resource pages IVDR:
- NoMA’s website
- Guidance documents from MDCG; medical device coordination group
