Report clinical trials with medical devices under MDR

There are three types of clinical trials of medical devices that must be reported. It is the purpose of the trial that defines what type of trial it is and where it should be reported:

Trials of medical devices intended to obtain the CE mark or expand the CE marking (Article 62 and 74(2))

• If you conduct trials of medical devices in order to get the CE marking, you must report it to both the Medical Scientific Ethical Committees (MREC) and the Danish Medicines Agency (Article 62).
• If you conduct trials of CE marked medical devices outside of the intended purpose with a view to expanding the CE marking, you must report it to both the MREC and the Danish Medicines Agency (Article 74(2))

Application form for tests of medical devices (Articles 62 and 74(2))

• If you conduct post-marketing clinical follow-up studies of medical devices that are otherwise required to be reported to a scientific ethics committee, you must report it to the MREC. If the trial involves additional burdensome and/or invasive procedures compared to the device's CE marking, you must also notify the Danish Medicines Agency (Article 74.1). If you are unsure whether the trial involves additional burdensome or invasive procedures, contact the Danish Medicines Agency.

Application form for tests of medical devices (articles 74(1) and 82

• If you conduct trials of medical devices for purposes other than those stated in Article 62, 74(1) & 74(2), which involve additional procedures or behavioral regulation compared to normal clinical practice, you must report it to the MREC (Article 82). This could be, for example, researcher-initiated trials of already CE-marked medical devices (including head-to-head studies) or trials of early prototypes of medical devices without the intention of obtaining CE marking.

Application form for tests of medical devices (articles 74(1) and 82