April 2021: Denmark Regulatory Update

The new Danish Act on research ethics treatment of clinical trials of medical devices, etc., introduces changes in the rules governing the marketing of medical devices in Denmark. The amendment will adapt to Danish legislation under Regulation 2017/745 on medical devices (MDR) and Regulation 2017/746 on medical devices for in vitro diagnostics (IVDR).

The manufacturers’ duty to report to the Danish Medicines Agency may apply for six months after the EU Commission has announced that the joint European database for medical devices (EUDAMED) is operational. Then the rules of the regulation on manufacturers’ duty to report incidents, reports on results of investigations of incidents and safety-related corrective measures will apply directly, so that manufacturers must report through EUDAMED to the competent authorities.