Three types of clinical investigations of medical devices are subject to notification. The type of investigation and the body to notify depend on the purpose of the investigation.
Investigations of medical devices performed to obtain CE marking or to extend the CE marking (articles 62 and 74(2))
- If you perform clinical investigations of medical devices with the purpose of obtaining CE marking, you must notify it to both the Medical Research Ethics Committees (MREC) and the Danish Medicines Agency (article 62).
- If you conduct clinical investigations of CE marked medical devices outside the scope of their intended purpose with the purpose of extending the CE marking, you must notify it to both the MREC and the Danish Medicines Agency (article 74(2)).
Application form for the authorisation of clinical investigations of medical devices (articles 62 and 74(2))
Post-market clinical investigations of CE marked medical devices – clinical follow-up studies (article 74(1))
- If you conduct post-market clinical follow-up studies of medical devices that are otherwise subject to notification to a research ethics committee, you must notify it to the MREC. If the investigation involves additional invasive or burdensome procedures in relation to the device’s CE marking, you must also notify it to the Danish Medicines Agency (article 74(1)). If you are not sure whether the investigation involves additional invasive or burdensome procedures, please contact the Danish Medicines Agency.
Application form for the authorisation of clinical investigations of medical devices (articles 74(1) and 82)
Investigations of medical devices for other purposes (article 82)
- If you perform investigations of medical devices for purposes other than those listed in articles 62, 74(1) and 74(2) that involve additional procedures or behaviour deviation from normal clinical practice, you must notify this to the MREC (article 82). This could be researcher-initiated investigations of already CE marked medical devices (including head-to-head studies) or investigations of early stage prototypes of medical devices with no intention to obtain CE marking.
Application form for the authorisation of clinical investigations of medical devices (articles 74(1) and 82)
Modifications to investigations
See the guidance on how to notify modifications.
For notification of modifications to investigations that have already been reviewed by the MREC, the following application form for articles 62 and 74(2) must be used:
Application form for the authorisation to make substantial modifications to clinical investigations of medical devices (article 62)
And for article 74(1) og article 82 applications:
Overview of the most common modifications to the clinical investigation plan
See a list of the most common changes to the clinical investigation plan