Danish Medicines Agency Guidance for Medical Device Development

1. Manufacturer Responsibilities

Manufacturers bear full responsibility for ensuring their medical devices meet all legal requirements before placing them on the market. This includes correct classification, appropriate conformity assessment procedure, clinical evaluation, and CE marking where required. Source: Danish Medicines Agency Medical Device Development Page https://laegemiddelstyrelsen.dk/en/devices/development-of-medical-devices/

2. Key Development Steps

The Agency recommends following these steps:

• Determine if the product is a medical device.
• Classify the device according to risk rules.
• Choose the correct conformity assessment procedure.
• Conduct clinical evaluation and investigations if needed.
• Implement a quality management system.
• Prepare technical documentation.
• Affix CE marking (for classes above I).
• Register in EUDAMED.
• Perform post-market surveillance and vigilance. Source: Danish Medicines Agency Medical Device Development Page https://laegemiddelstyrelsen.dk/en/devices/development-of-medical-devices/

3. Classification and Conformity Assessment

Classification determines the conformity assessment route. Class I devices often allow self-certification, while higher classes require notified body involvement. Guidance documents from the European Commission and MDCG are referenced for detailed rules. Source: Danish Medicines Agency Medical Device Development Page https://laegemiddelstyrelsen.dk/en/devices/development-of-medical-devices/

4. Clinical Evaluation and Investigations

Clinical evaluation is mandatory for all devices to demonstrate safety and performance. For certain devices, clinical investigations are required. The Agency oversees notifications and approvals for investigations in Denmark. Source: Danish Medicines Agency Medical Device Development Page https://laegemiddelstyrelsen.dk/en/devices/development-of-medical-devices/

5. Quality Management and Documentation

A quality management system compliant with MDR is essential. Technical documentation must be comprehensive and maintained throughout the device lifecycle. Source: Danish Medicines Agency Medical Device Development Page https://laegemiddelstyrelsen.dk/en/devices/development-of-medical-devices/

6. Post-Market Obligations

Ongoing post-market surveillance, vigilance reporting, and periodic safety updates are required to monitor device performance after market placement. Source: Danish Medicines Agency Medical Device Development Page https://laegemiddelstyrelsen.dk/en/devices/development-of-medical-devices/

7. Additional Resources and Contact

The Agency links to EU legislation, MDCG guidance, and specific topics like software, AI, and custom-made devices. For questions, contact the Medical Devices team. Telephone: +45 4488 9595 (weekdays 9-12) Email: Send a message via the contact form Source: Danish Medicines Agency Medical Device Development Page https://laegemiddelstyrelsen.dk/en/devices/development-of-medical-devices/