Notification Requirements for Clinical Investigations of Medical Devices in Denmark

1. Overview

Notification duty for clinical investigations depends on whether the device is CE marked and the purpose of data collection. The MDR distinguishes three main types: investigations under Article 62 for non-CE marked devices or off-purpose use; Article 74(1) for PMCF with additional invasive/burdensome procedures; and Article 82 for other investigations. Source: Danish Medicines Agency Notification Duty Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/notification-duty/

2. Article 62 Investigations (Product Development)

These cover pre-market investigations for non-CE marked devices or CE marked devices used outside intended purpose to expand/modify it. A single common application must be submitted simultaneously to the Danish Medicines Agency and Medical Research Ethics Committees before commencement. Source: Danish Medicines Agency Notification Duty Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/notification-duty/

3. Article 74(1) Investigations (PMCF with Additional Procedures)

For CE marked devices in PMCF involving additional invasive or burdensome procedures, the sponsor notifies the Danish Medicines Agency 30 days before commencement, while seeking authorization from Medical Research Ethics Committees. Source: Danish Medicines Agency Notification Duty Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/notification-duty/

4. Article 82 Investigations (Other)

These have minimum requirements and are submitted to Medical Research Ethics Committees. The manufacturer must document compliance with Annex I general safety and performance requirements (except investigated aspects). Source: Danish Medicines Agency Notification Duty Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/notification-duty/

5. Who Must Notify

The manufacturer or sponsor (or their legal representative) is responsible for notification and ensuring compliance. Source: Danish Medicines Agency Notification Duty Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/notification-duty/

6. Application and Documents

For Article 62, use the common application form available for download. Applications are processed via the national system. Source: Danish Medicines Agency Notification Duty Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/notification-duty/

7. Additional Guidance and Legislation

Refer to MDCG 2021-6 Rev. 1 for Q&A on clinical investigations. Legislation: Regulation (EU) 2017/745 (MDR) Articles 62-82. Source: Danish Medicines Agency Notification Duty Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/notification-duty/ MDCG Guidance: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en#sec4