Clinical investigation of medical devices
Clinical investigations that must be notified to the Norwegian Medicines Agency
- Clinical investigations of medical devices that are not CE marked
- Clinical investigations of medical devices that are CE marked, but where the device will be used outside the scope of the intended use designated by the current CE mark
For such investigations, a notification must be sent to the Norwegian Medicines Agency prior to starting the investigation. In addition, approval from the Regional Committees for Medical and Health Research Ethics (REK) must be obtained.
Clinical investigations of CE marked medical devices used within the scope of the intended use, as designated by the CE mark, shall not be notified to the Norwegian Medicines Agency (but may still need approval from REK). If in doubt whether an investigation should be notified or not, please contact us.
Clinical documentation of medical devices
In order to affix the CE mark to a medical device the manufacturer must declare that the device conforms to the essential requirements specified in Annex ØMU I (lovdata.no) and AIMU I (lovdata.no) in the Regulation of 15 December 2005 no 1690 on medical devices (lovdata.no), which implements Annexes I and 1 in Council Directives 93/42/EEC and 90/385EEC. The manufacturer bears the sole responsibility for documenting that the medical device is safe to use and performs as intended. As part of the process to document safety and performance, a clinical evaluation must be performed. A clinical evaluation may be based on existing clinical data, depending on the nature of the existing data and the medical device. However, if existing data are not sufficient, a clinical investigation must be conducted to obtain new clinical data. For active implantable devices and class III devices, a clinical investigation must be performed unless it is duly justified to rely on existing clinical data.
The clinical investigation must be designed to obtain relevant data, including on the safety and/or performance of the device. Exploratory studies (other terminology: pilot-, feasibility-, early-, proof-of-concept studies), may not provide sufficient data to meet the regulatory requirements for CE marking, but may provide the basis for subsequent confirmatory (pivotal) studies. Regardless of study design, the clinical investigation should be notified to the Norwegian Mecines Agency.
Notification of a clinical investigation of a medical device
A notification must sent to the national competent authority (NCA) in all EEA/EU states where the investigation is going to take place (in Norway; the Norwegian Directorate of Health) at least 60 days prior to the planned initiation of the investigation. In addition, approval from the relevant ethics committee in each state must be obtained (In Norway; the Regional Committees for Medical and Health Research Ethics).
To submit a notification, please e-mail the notification form (DOC) with all mandatory attachments to firstname.lastname@example.org or send by mail to the Norwegian Medicines Agency, P.O. Box 6167 Etterstad, 0602 Oslo, Norway. For further information, please see our guidance document (PDF) on how to complete the notification form.
The Norwegian Medicines Agency will review the documentation and inform the sponsor of whether there are any objections to the initiation of the investigation. If the sponsor has not been notified by the The Norwegian Medicines Agency within 60 days of the notification, the clinical investigation may commence. The Directorate of Health may however inform the sponsor of its decision before the end of the 60 day period. If additional information has to be requested from the sponsor, the 60 day time period will be put on hold until the requested documentation has been received.
notification form (DOC)
guidance document (PDF)
Regulatory framework/guidance documents:
- Regulation of 15 December 2005 no 1690 on medical devices § 4-5, § 5-6, Annex/vedlegg AIMU I, AIMU VI, AIMU VII, ØMU I, ØMU VIII, ØMU X) (In Norwegian)
- Directive 93/42/EEC (Article 15, Annexes I, VIII, X), directive 90/385/EEC (Article 10, Annexes 1, 6, 7)
- MEDDEV 2.7/1 Clinical evaluation: Guide for manufacturers and notified bodies (incl. Appendix 1 Clinical Evaluation of Coronary Stents)
- MEDDEV 2.7/2 Guide for Competent Authorities in making an assessment of clinical investigation notification
- ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
The following must be reported to the Norwegian Medicines Agency after initiation of the investigation
Serious adverse events (SAE)
All serious adverse events must fully be recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed (Regulation of 15 December 2005 no 1690 on medical devices, Annexes AIMU VII and ØMU X (lovdata.no)). Sponsor must report to the Norwegian Directorate of Health, and, if the investigation takes place in other EEA countries, to the NCAs of those countries.
Link to Reporting form for SAEs
(See Guidance MEDDEVs, under 2.7 Clinical investigation, clinical evaluation, MEDDEV 2.7/3-SAE reporting form)
For guidance, please see MEDDEV 2.7/3 Clinical investigations: serious adverse reporting. Please also consult NS-EN ISO 14155:2011.
Amendments to the clinical investigation plan
Significant amendments to the clinical investigation plan must be notified to the Norwegian Medicines Agency.
Termination of the investigation
The Norwegian Medicines Agency must be notified of the end of the investigation, with a justification in case of early termination.
Clinical Investigation Report
A final report for the investigation shall be submitted. Annex D of EN ISO 14155 provides guidance on the content and format of the report (informative only).
For questions, please contact us by e-mail email@example.com or call the Norwegian Medicines Agency +47 22 89 77 00 (switchboard).