Assessment Process for Clinical Investigations of Medical Devices in Denmark

1. Validation Phase

The Danish Medicines Agency validates applications within 15 calendar days of receipt, checking if the investigation falls under the regulation (involves a medical device and requires authorisation) and if all required information is complete. If valid and complete, a validation date is assigned, starting the assessment. If incomplete or invalid, the sponsor receives notification by day 15 and has 30 days to resubmit all missing elements in one email to both the Agency and ethics committees. Re-submissions are assessed within 10 days. Source: Danish Medicines Agency Assessment Information Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/information-about-the-assessment/

2. Assessment Phase

The Agency has 45 calendar days from the validation date to assess and decide. The timeline may be suspended from the date additional information is requested until received. Sponsors must reply completely in one email to both the Agency and ethics committees. Source: Danish Medicines Agency Assessment Information Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/information-about-the-assessment/

3. Decision and Commencement

Investigations may start upon Agency authorisation, considering the ethics committees' opinion. Decisions must be made within 45 days of validation, though often longer due to suspensions for additional information. Source: Danish Medicines Agency Assessment Information Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/information-about-the-assessment/

4. Responsibilities of the Danish Medicines Agency

The Agency assesses applications, grants authorisation, and may require annual safety reports listing serious adverse events in Denmark and abroad, with risk-benefit assessment and subject safety conclusion. For implants or devices with potential systemic absorption or pregnancy risks, protocols must ensure non-pregnant women of childbearing potential (negative test) and adequate contraception, justified in duration. Accepted methods include intrauterine devices, hormonal contraceptives; double barrier or sterilised partners may be justified in special cases. Source: Danish Medicines Agency Assessment Information Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/information-about-the-assessment/

5. Role of Ethics Committees

Medical Research Ethics Committees provide an opinion considered in authorisation. Sponsors submit replies to questions simultaneously to the Agency and committees. Source: Danish Medicines Agency Assessment Information Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/information-about-the-assessment/

6. Application Content Requirements

Detailed information requirements are in Appendix XV of the regulation, covering the investigation plan and investigator’s brochure. Source: Danish Medicines Agency Assessment Information Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/information-about-the-assessment/