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Clinical investigations of medical devices

28 July 2015

Information about clinical investigations of medical devices and how to apply for authorisation for clinical investigations.

Clinical investigations of medical devices carried out in human subjects are any investigations in humans, which serve the purpose of verifying or testing the safety and/or performance of a medical device.

The device to be investigated may be a new medical device or a well-known medical device already placed on the market in Denmark.

The Danish Data Protection Agency

After the entry into force of the General Data Protection Regulation, clinical investigation of medical devices should no longer be notified to the Danish Data Protection Agency.

Read more on the website of the Danish Data Protection Agency.

Contact the Danish Data Protection Agency at dt@datatilsynet.dk or call +45 33193200.

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