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:
- A completed application form.
- Scientific documentation corresponding to the dossier requirements as outlined in the EMA document for consultations.
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 78,590 DKK will be charged to the Notified Body per medical device (product number 4121).
Supplementary consultations
Before any change is made with respect to an ancillary substance incorporated in a device, e.g. its manufacturing process, the manufacturer must inform the Notified Body of the changes. The Notified Body shall seek the opinion of the Competent Authority originally consulted, to confirm that the quality and safety of the ancillary substance remain unchanged. This opinion is called a supplementary consultation or variation application.
The Notified Body submits a request to DKMA consisting of:
a) A completed variation application form.
b) Scientific documentation for the variation corresponding to that described in Commission Communication C/2025/5025, dated 22.9.2025 for variations for medicinal products for human use.
Following receipt of all necessary information, the assessment report with opinion will be sent by DKMA to the Notified Body within 60 days.
Fees
None