Other clinical investigations
Not all clinical investigations require application or notification to NOMA. Here you will find information regarding which clinical investigations fall into this category. Please note that there are still formal requirements to these investigations.
Which clinical investigations do not require application or notification to NOMA?
Clinical investigons which meet the requirements below do not require application or notification to NOMA:
- The device is CE marked and will be investigated within the scope of its intended purpose as defined by the manufacturer. Please note that there may be changes for high-risk devices during 2021 and 2022.
- The device is CE marked and subjects are not subjected to invasive or burdensome procedures which are additional to those performed under normal conditions of use.
Please consult the European Commission’s Q&A regarding clinical investigations for guidance on what is considered an invasive or burdensome procedure.
What are the requirements for these clinical investigations?
It is the responsibility of the sponsor to ensure that clinical investigations which do not require application or notification to NOMA fulfil the requirements specified in MDR Article 82. NOMA has been given mandate to conduct surveillance of these clinical investigations. Upon inspection, the sponsor will be requested to provide documentation in accordance with the requirements of MDR Article 82.
A summary of the requirements:
- An application must be submitted to the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU).
- A sponsor outside of the EU/EEA must have a legal representative within the EU/EEA.
- The rights, safety, dignity, and well-being of the subjects participating in the clinical investigation are protected and prevail over all other interests.
- The clinical data generated must be scientifically valid, reliable, and robust.
- Vulnerable populations and subjects must be appropriately protected.
- The subject must give informed consent.
- The investigational device in question conforms to the applicable general safety and performance requirements for medical devices.
- The principal investigator and other co-investigators must be sufficiently qualified.
Please refer to MDR Article 82 for a complete list of requirements.