Other performance studies

What requirements apply?

The general requirements apply to all performance studies, this includes studies that do not require an application or a notification to NOMA. 

The general requirements are outlined in IVDR Article 57:

1. The manufacturer shall ensure that a device for performance study 
   complies with the general safety and performance requirements set out 
   in Annex I apart from the aspects covered by the performance study and 
   that, with regard to those aspects, every precaution has been taken to 
   protect the health and safety of the patient, user and other persons.
2. Where appropriate, performance studies shall be performed in
   circumstances similar to the normal conditions of use of the device.
3. Performance studies shall be designed and conducted in such a 
   way that the rights, safety, dignity and well-being of the subjects participating in such performance studies are protected and prevail over all 
   other interests and the data generated are scientifically valid, reliable 
   and robust.

Performance studies, including performance studies that use left-over 
samples, shall be conducted in accordance with applicable law on 
data protection.

An application to The Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU) is still required for these performance studies. For more information, see REK KULMUs website.