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February 9, 2026
Approximately 5 minutes
Danish Medicines Agency Regulatory Advice for Medical Device Companies
Danish Medicines Agency Regulatory Advice for Medical Device Companies
1. Overview of the Service
The Danish Medicines Agency provides regulatory advice specifically targeted at startups, small and medium-sized enterprises (SMEs), and educational or research units involved in medical devices. This service responds to increasing needs for guidance on the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). Advice is delivered through individual one-to-one meetings, either in person or via teleconference. Source: Danish Medicines Agency Regulatory Advice Page https://laegemiddelstyrelsen.dk/en/devices/regulatory-advice-for-medical-device-companies/
2. Scope of Advice
The advice covers:
- Applicable regulations for medical devices.
- Requirements and processes for applications related to clinical investigations for specific products.
- General regulations concerning CE marking. The goal is to help companies and units navigate and comply with EU regulatory frameworks effectively. Source: Danish Medicines Agency Regulatory Advice Page https://laegemiddelstyrelsen.dk/en/devices/regulatory-advice-for-medical-device-companies/
3. What is Not Covered
The service explicitly excludes:
- Classification of specific devices or risk classification advice.
- Approval of medical devices.
- Assessment of documents submitted for clinical investigation applications.
- Positions on specific issues that may be subject to Agency decisions.
- Commercial or scientific advice.
- Advice for consultants or private advisers. Source: Danish Medicines Agency Regulatory Advice Page https://laegemiddelstyrelsen.dk/en/devices/regulatory-advice-for-medical-device-companies/
4. How to Request Advice
To request a meeting:
- Complete the provided form.
- Submit via email. The Agency aims to confirm a meeting date within 14 days of receipt. Source: Danish Medicines Agency Regulatory Advice Page https://laegemiddelstyrelsen.dk/en/devices/regulatory-advice-for-medical-device-companies/
5. Fees and Limitations
No fees are charged for the regulatory advice or meetings. The advice is non-binding and based on current knowledge at the time of the meeting. Source: Danish Medicines Agency Regulatory Advice Page https://laegemiddelstyrelsen.dk/en/devices/regulatory-advice-for-medical-device-companies/
6. Contact and Resources
Requests should be submitted using the forms linked on the page. The service is managed by the Danish Medicines Agency's Medical Devices team. Source: Danish Medicines Agency Regulatory Advice Page https://laegemiddelstyrelsen.dk/en/devices/regulatory-advice-for-medical-device-companies/
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