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 14155:2020 standard “Clinical investigation of medical devices for human subjects – Good clinical practice” may be purchased from Danish Standards at https://webshop.ds.dk/en.

Authorisation from subjects participating in clinical investigation permitting the Danish Medicines Agency to access patient records during inspection of a clinical investigation

In connection with the inspection of a clinical investigation, the Danish Medicines Agency is permitted to access any patient records held at the investigation site. This means that as of 26 May 2021, the Danish Medicines Agency no longer needs an authority from the subjects participating in the investigation. 

However, the participant information must detail that the subjects have been informed that the sponsor, its representative, e.g. a monitor, and the Danish Medicines Agency may gain access to patient records as part of their control or inspection activities related to the investigation.

However, if the sponsor assesses that it might become relevant for the investigation site to be inspected by foreign health authorities (e.g. the FDA), the sponsor is required to obtain authorisation from the subjects for this particular purpose.

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.