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February 6, 2026
Approximately 5 minutes
Derogation from CE Marking for Medical Devices in Denmark
Derogation from CE Marking for Medical Devices in Denmark
1. Definition and Purpose
Derogation permits the use of a specific medical device in Denmark without a conformity assessment (and thus without CE marking), pursuant to Article 59 of the MDR and Article 54 of the IVDR. It is granted for a limited period where necessary to protect public health or patient safety or health. Source: Danish Medicines Agency Derogation from CE Marking Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/derogation-from-ce-marking/ MDR Article 59: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20240709 IVDR Article 54: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20240709
2. Eligibility and Applicants
Only the manufacturer, authorised representative, or a person/company authorised by the manufacturer may apply for derogation. Source: Danish Medicines Agency Derogation from CE Marking Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/derogation-from-ce-marking/
3. Application Process
Applications must use the official form and include:
- Statement from a Danish healthcare professional justifying necessity and potential impact on public health or patient safety if the device is unavailable.
- List of Danish recipient organisations and device types/models.
- Number of units and requested duration.
- List of alternative devices/procedures on the market, shared with the healthcare professional. One form may cover multiple devices in the same treatment/procedure if clearly specified; separate forms required for unrelated devices. Source: Danish Medicines Agency Derogation from CE Marking Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/derogation-from-ce-marking/ Application Form: https://laegemiddelstyrelsen.dk/da/udstyr/registrering-og-marketsfoering/dispensation-fra-krav-om-ce-maerkning/~/media/4DACF75EA07641A796995DD4F4625C02.ashx
4. Assessment Criteria
The key criterion is the healthcare professional's statement addressing alternatives and demonstrating necessity. Source: Danish Medicines Agency Derogation from CE Marking Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/derogation-from-ce-marking/
5. Conditions and Duration
Derogation is time-limited and granted only to safeguard public health or patient safety/health. Duration is as requested in the application. Source: Danish Medicines Agency Derogation from CE Marking Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/derogation-from-ce-marking/
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