Notification of PMCF investigation

PMCF investigations where the investigation involves submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome must, in addition to being subject to an opinion from the Medical Research Ethics Committees, be notified to the Danish Medicines Agency 30 calendar days before the investigation’s planned commencement.

The investigation is not subject to authorisation by the Danish Medicines Agency, but the agency may decide that the investigation should be modified or terminated pursuant to article 76 of the regulation.

The Danish Medicines Agency has 30 calendar days to obtain more information from the sponsor and to inform the sponsor, for example if the agency intends to request the sponsor to modify the clinical investigation.

The sponsor sends an email which briefly describes the investigation, details what other additional invasive or burdensome procedures the subjects will be submitted to, along with contact details of the sponsor of the investigation, contact details of the medical device manufacturer and contact details of the Danish investigators that will be participating in the investigation. The positive opinion from the Medical Research Ethics Committees must also be attached.

When PMCF investigations are notified to have started, any serious adverse events arising during the investigation must be reported to the Danish Medicines Agency in accordance with the following:

Any serious adverse events arising during these investigations and where a causal relationship has been established between the serious adverse event and the applied investigation procedure which, pursuant to the above, was notified to the Danish Medicines Agency as an additional invasive or burdensome procedure, must be reported to the Danish Medicines Agency as a serious adverse event (SAE), see MDCG 2020-10.

Any serious events that are related to medical devices must be reported to the Danish Medicines Agency as a serious event in accordance with the provisions appearing from the general rules for safety monitoring of medical devices. Find out more here.