Clinical investigation of medical devices
This page gives information about clinical investigation of medical devices and how to apply for authorisation of a clinical investigation.
A clinical investigation of medical devices in human subjects is any investigation in human subjects intended to discover or verify the safety and/or performance of a medical device.
The device being tested could be a new medical device or a well-established medical device already on the Danish market.
If a sponsor contemplating to submit an application for clinical investigation is not sure if the device in question is a medical device or if it falls under Annex XVI (products without an intended medical purpose), or if a sponsor is unsure if an application for authorisation of a clinical investigation is required, we ask the sponsor to contact the Danish Medicines Agency for clarification before submitting an application for authorisation.
International standard for clinical investigation of medical devices available from Danish Standards
The DS/EN ISO 14155:2026 standard “Clinical investigation of medical devices for human subjects – Good clinical practice” may be purchased from Danish Standards at https://webshop.ds.dk/en.
Access to patient records in connection with the inspection of a clinical investigation
In connection with an inspection of a clinical investigation, the Danish Medicines Agency has access to the patient records that may be held at the investigational site.
However, it must be stated in the participant information that the participant has been informed that the sponsor, the sponsor’s representative (e.g. a monitor), the Danish Medicines Agency, and foreign health authorities have access to the medical records in connection with supervision and inspection of the investigation.
Relationships
In matters of clinical investigation, it is relevant for sponsors and investigators to study the rules requiring companies and healthcare professionals to notify relationships to the Danish Medicines Agency. For guidance on these rules, please contact the Danish Medicines Agency, or read the rules here.