Performance studies of in vitro-diagnostic medical devices (IVDs)
A performance study is carried out to establish the analytical or clinical performance of an IVD. IVDR lists requirements for performance studies to ensure valid, reliable and robust generated data, and that the participaters rights are protected.
Clinical performance studies should be prepared in accordance with good study practice as described in the standard ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice.
All performance studies that entail risks for the subjects shall, in general, be applied for or notified to NOMA before the study may start. Performance studies that require an application or notification to NOMA must also be approved by the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU).
The European medical devices database, EUDAMED, is delayed. Until EUDAMED is fully functional, all communication and submission of applications to NOMA shall be done via e-mail to email@example.com.