MDStudy object
MD - Definition available in national law
Yes
MD - Definition
Definitions are provided in Chapter 1 of The Ministry of Health’s executive order no. 1263 of 15 December 2008 on medical devices (in Danish only).
Investigation of MD - Definition available in national law
Yes
Investigation of MD - Definition
„Any investigations on humans which serve the purpose of verifying or testing the safety and/or performance of a medical device“ (Definition according to part 2, section 2 of the Committee Act and Chapter 1 of The Ministry of Health’s executive order no. 1263 of 15 December 2008 on medical devices)
