Consultation procedure for medical devices containing medicinal substances

Consultation procedure for medical devices containing medicinal substances

Medical devices may contain a substance that is an integral part of the medical device, but which would be a medicinal product when used separately. When evaluating such devices, a Notified Body must consult an EU Competent Authority such as the Danish Medicines Agency (DKMA) for verification of the quality, safety and usefulness of the medicinal substance in the medical device. The opinion given by the Competent Authority is to be taken into account by the Notified Body in the overall assessment of the medical device.  The final decision on whether or not to certify the medical device lies with the Notified Body.

Consultation process

To start the consultation procedure, the Notified Body submits a request to DKMA consisting of:

1. A completed application form.
2. Scientific documentation corresponding to the dossier requirements as outlined in the EMA document for consultations.

Send an email with all your requests. 

Following receipt and validation, the assessment report with opinion will be sent by DKMA to the Notified Body following a 210-day procedure.

Fees

In accordance with Executive Order no. 1100, 01/06/2021 § 11, a fee of 73,085 DKK will be charged to the Notified Body per medical device (product number 4121).