MDStudy object

Yes

Definition of MD is provided in Art 3 Act on MD no. 16/2001 and Art 2(1) Regulation no. 934/2010.
Definition of a 'Device intended for clinical investigation' is provided in Art 2(5) Regulation no. 934/2010.

Yes

Definition pursuant to Art 3 Act on MD no. 16/2001:
'Clinical investigation: means research on humans for the purpose of obtaining information and/or verifying that medical devices, in normal use, conform to basic requirements on characteristics and performance, as provided for in the EU Directives which form a part of the Agreement on the European Economic Area and the Convention establishing the European Free Trade Association. Clinical investigations include assessment of undesired side-effects of medical devices.

A device which forms part of a medical device, or which is in any other way connected with the use of a medical device shall also constitute a medical device.
A device which primarily has an effect on or in the human body by pharmacological, immunological or metabolic means does not constitute a medical device, although it may form a part of a medical device.
IMA will make the final decision on the classification, if it is unclear.