Danish Medicines Agency Recommended New Regulation for Application for a Clinical Trial Permit for Medical Devices

Danish Medicines Agency recommended a new regulation on medical devices (MDR 2017/745) is effective from 26 May 2020, new rules on clinical trials. Applications for clinical trials have to be processed in accordance with the rules of the Regulation of 26 May 2020.

Thus, from May 26, 2020, the Danish Medicines Agency can no longer process applications for clinical trials as per the rules in Executive Order No. 1263 of December 15, 2008 on medical devices and Executive Order No. 1264 of December 15, 2008 on active, implantable medical devices. The orders will be cancelled with effect from May 26, 2020. Thus, the Danish Medicines Agency cannot approve clinical trials in accordance with the rules in the regulations of May 26, 2020.

As the Danish Medicines Agency’s maximum preparing time after the Order on Medical Devices and the Order on Active Implantable Medical Devices is 60 days, we recommend that sponsors wishing to apply for clinical trial authorization after the orders submit a duly drafted application by March 26, 2020 in order for the Danish Medicines Agency to finalize the application before the rules of the regulation apply.

The Danish Medicines Agency must also point out that a clinical trial that is subject to a license under the regulations must be started before May 26, 2020. 11 that clinical trials commenced in accordance with Article 10 of Directive 90/385 on active implantable medical devices or Article 15 of Directive 93/42 on medical devices may be continued before 26 May 2020.

A clinical trial is considered to have initiated when a study-specific activity has been commenced to recruit first test subject (s), eg in the form of advertising, recruitment notice or when first prospective test subject has been informed of the trial.