Other performance studies
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Changes
Performance studies that do not fall under Article 58 (1), 58 (2) or 70 in the IVDR shall not be applied for or notified to NOMA. Such studies may commence without the involvement of NOMA, but must still meet the general requirements in IVDR.
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 Committee (REK) is still required for these performance studies. For more information, see REK KULMUs website.
EU regulations on medical devices
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