Recommendations from Danish Medicines Agency on Applications for authorisation of clinical investigation of medical devices
The new Regulation on Medical Devices (MDR 2017/745) will apply from 26 May 2020. The regulation sets out, among others, new rules for clinical investigations. Applications for authorisation of clinical investigation will thus be assessed according to the new rules from 26 May 2020.
After 26 May 2020, Danish Medicines Agency can no longer assess applications for authorization of clinical investigation according to the MD/AIMD Directives as implemented in Denmark as the Executive order no. 1263 of 15. December 2008 on medical devices and Executive order no. 1264 of 15. December 2008 on active, implantable medical devices. These legislations will be repealed as of 26 May 2020 in Denmark, and Danish Medicines Agency cannot authorize clinical investigations according to these executive orders after 26 May 2020.
As the maximum casework time for Danish Medicines Agency, for an assessment of an application for authorisation of a clinical investigation of a medical device, is 60 calendar days, we recommend that sponsors who wish to apply for an authorisation of a clinical investigation under the above-mentioned executive orders, submits a complete application the 26 March 2020 at the latest, for us to be able to complete or assessment prior to 26 May 2020, where the new regulation will apply.
Further, Danish Medicines Agency also wish to point out that a clinical investigation, that holds an authorization according to the executive orders in Denmark, shall have started to be conducted prior to 26 May 2020. This follows the requirement in the Medical Device Regulation article 120(11), where it is stated that clinical investigations which have ‘started to be conducted’ in accordance with Article 10 of Directive 90/385 on active implantable medical devices or Article 15 of Directive 93/42 on medical devices, prior to 26 May 2020, may continue to be conducted.
The Danish Medicines Agency finds that a clinical investigation can be considered ‘started to be conducted’ once a study-specific activity has started in order to recruit the first participant(s), i.e. advertising, recruitment notices, or when the first potential participant has received information on the clinical investigation.