Derogation from CE marking

Under article 59 of the MDR and article 54 of the IVDR, a competent authority may authorise the use of a specific medical device within the territory of the concerned member state even in the absence of a conformity assessment.

Derogation is generally only possible for a limited period to safeguard public health or patient safety or health.

Applying for permission to market non-CE marked medical devices
Only the manufacturer, their authorised representative, or a person/company authorised by the manufacturer, may apply for a derogation.

The application must include several statements, one of which must be from a Danish healthcare professional, to demonstrate the necessity of authorising the device on the Danish market and to highlight the potential impact on public health or patient safety and health if the device is no longer available.

Additionally, the application must include a list of Danish recipient organisations and a list of the types of devices and models they use. Information about the number of units to be covered by the derogation and for how long the authorisation is needed should also be provided.

The applicant must include a list of alternative devices on the market and/or any alternative medical procedures along with information on how these differ from the device for which the derogation is sought.

The list of alternative medical devices and/or procedures should be shared with the healthcare professional. It is important that the healthcare professional considers and addresses each alternative in their statement.

If you want to apply for several devices that are used in the same treatment or procedure, you may use one application form, but ensure that all device particulars are clear for each device.

If you want to apply for multiple devices that are not used in the same treatment or procedure, please fill out separate application forms, even if the devices may have been covered by the same certificate.