For testing in connection with CE marking of medical devices involving humans, special requirements have been established. These are regulated in a separate regulation and in the ISO standard “Clinical investigation of medical devices for human subjects – Good clinical practice” (ISO 14155)*. The NorCRIN procedure “MU SOP Clinical Trials Medical Device v.2.1” summarises these requirements. This update is in the first instance a clarification of the SOPs’ scope, plus separate monitoring reports for use in these trials have been added.
When testing medical devices where the results are not to be used for CE marking, no such special requirements have been established and the Norwegian Health Research Act applies. A guide is available for such health research projects (see Other interventions (AI)).
* ISO 14155 was updated in July 2020, and has as a result become more in line with ICH GCP (R2) through the inclusion of a separate chapter on the GCP principles and the introduction of a risk-based approach throughout the study process, as well as the inclusion of clinical quality management. A new version of the MU SOP is now being prepared that will address the revision of the ISO standard.
In the spring of 2021, a new regulation for medical devices (postponed due to the Covid-19 pandemic) will be implemented. In connection with this, a new MU SOP will be prepared and published.