Performance Studies for In Vitro Diagnostic Medical Devices in Denmark

1. Overview and Regulatory Basis

Performance studies for in vitro diagnostic medical devices (IVDs) in Denmark are regulated under the IVDR, specifically Article 58, which determines whether authorisation or notification to the Danish Medicines Agency is required. Source: Danish Medicines Agency Performance Studies Page https://laegemiddelstyrelsen.dk/en/devices/performance-studies-of-in-vitro-diagnostic-medical-devices-ivds/

2. Studies Requiring Authorisation

Authorisation from the Danish Medicines Agency is required for performance studies involving:

• Surgically invasive sample-taking solely for the purpose of the performance study.
• Studies where test results influence patient management or treatment decisions.
• Additional invasive procedures or other risks for subjects. Companion diagnostics follow the same requirements unless using only left-over samples. Source: Danish Medicines Agency Performance Studies Page https://laegemiddelstyrelsen.dk/en/devices/performance-studies-of-in-vitro-diagnostic-medical-devices-ivds/

3. Studies Requiring Notification

Notification (30 days prior via email) is required for:

• CE-marked IVDs with additional invasive or burdensome procedures, including a short study description and ethics committee opinion if applicable.
• Non-CE marked companion diagnostics using only left-over samples (no intervention or additional risks), with specific details: sponsor information, analysis sites, device manufacturer, device description, corresponding medicinal product, study details, and sponsor confirmation of no impact on treatment. Source: Danish Medicines Agency Performance Studies Page https://laegemiddelstyrelsen.dk/en/devices/performance-studies-of-in-vitro-diagnostic-medical-devices-ivds/

4. Ethics Committee Involvement

A positive opinion from Medical Research Ethics Committees is required for certain studies and must be attached to notifications where applicable. Source: Danish Medicines Agency Performance Studies Page https://laegemiddelstyrelsen.dk/en/devices/performance-studies-of-in-vitro-diagnostic-medical-devices-ivds/

5. Standards and Guidance

Studies should follow DS/ISO 20916:2019 - In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice. Guidance on combined studies with clinical trials is available. Source: Danish Medicines Agency Performance Studies Page https://laegemiddelstyrelsen.dk/en/devices/performance-studies-of-in-vitro-diagnostic-medical-devices-ivds/ Standard: https://webshop.ds.dk/ Combined Studies Guidance: https://laegemiddelstyrelsen.dk/en/licensing/clinical-trials/combined-studies-with-a-clinical-trial-and-a-simultaneous-performance-study/