Clinical investigation of medical devices
Here you will find information about clinical investigation of medical devices and about how to apply for authorisation to conduct a clinical investigation.
A clinical investigation of medical devices on humans is any investigation intended to establish or verify the safety and/or performance of a medical device.
The device being tested can be a new medical device, or it can be a medical device already marketed in Denmark.
International standard for clinical investigation of medical devices available from Danish Standards
The DS/EN ISO 14155:2020 standard “Clinical investigation of medical devices for human subjects – Good clinical practice” is available from Danish Standards and can be purchased at https://webshop.ds.dk.
Authority from research participants for the Danish Medicines Agency to access patient records in connection with the inspection of clinical investigations
The Danish Medicines Agency may as part of its inspection of clinical investigations access any patient records held at the investigation site. This means that, as of 26 May 2021, the Danish Medicines Agency no longer needs an authority from the research participant.
However, it must appear from the participant information that the research participant has been informed that the sponsor, the sponsor’s representative, e.g. the monitor, and the Danish Medicines Agency have access to records in connection with any inspection of the investigation.
If the sponsor considers that it might be relevant for the investigation site to be inspected by a foreign health authority (e.g. the FDA), the sponsor is still required to obtain an authority from the research participant to that effect.
The EU Commission's guidance on the content and structure of the summary of the clinical investigation report
The requirements for the clinical investigation report can be found in Annex XV, chapter III, point 7 of the Medical Devices Regulation, and in Annex D of the DS/EN ISO 14155:2020 standard. Furthermore, the EU Commission has published a guidance on the content and structure of the summary of the clinical investigation report. The guidance can be found here.