Clinical investigations for medical devices, which include testing of medicinal products
If you apply for a clinical trial/investigation, which includes the testing of a medicinal product against a medical device that is not CE marked for the intended purpose, you only have to submit one electronic application to the Danish Medicines Agency.
How to submit the application
Companies, including CROs (Contract Research Organisations), can apply for clinical trials of medicines in humans, which also include the testing of medical devices, via DKMAnet, our access-controlled extranet: Applicants who do not have access to DKMAnet can send the documentation electronically on CD-ROM or via Eudralink.
- Applying for clinical trial authorisations via DKMAnet
- Clinical trial applications on CD-ROM or via Eudralink
Please specify in your cover letter that you apply for this type of investigation.
The application must include the following documents:
- completed EudraCT form and related documentation according to the Danish Medicines Agency's applicable Guideline for applications for authorisation of clinical trials of medicinal products in humans
- The Danish Medicines Agency's application form and related documentation according to the Danish Medicines Agency's Guidance on application for the authorisation for clinical investigation of medical devices
Note that the executive order on clinical trials of medicinal products in humans and relevant executive orders on medical devices must be complied with.
Please note that we charge a fee for both the application for clinical trials of medicinal products and the application for clinical investigations of medical devices
The scientific assessment will start when we have received your full submission, which means that our Clinical Trials and Medical Devices units must have validated the documentation submitted.
During the parallel validation, the Clinical Trials and Medical Devices units may write to you if we require additional information for the assessment.
Both the Clinical Trials and Medical Devices units will make a decision.