Combined studies with a clinical trial and a simultaneous performance study

Please note that there is an error in some of the email addresses in the guide. The IVDR application must be sent to the Danish Medicines Agency and the Medical Research Ethics Committees.

Danish Medicines Agency, in collaboration with Danish Medical Research Ethics Committees, has developed a new guideline allowing sponsors of combined studies with a clinical trial involving simultaneous performance study of a in vitro diagnostic devices, to apply for approval through a national coordinated process. This coordinated process ensures that sponsors receive simultaneous decisions on both the clinical trial and the performance study. It is voluntary for sponsors to apply through a coordinated process.

Link to the guideline.

The Danish Medicines Agency is also responsible for coordinating EU collaboration under the project 'COMBINE'.