MDStudy object

Yes

Medical Devices (MDs):
'any device intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, compensation for an injury or handicap.
In addition some devices for control of conception, and devices for disabled fall under the definition.'
Medical devices are further defined in Regulation of 15 December 2005 no 1690 on medical devices § 1-5a.

Active implantable medical device (AIMD): 'any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure' (ref Regulation of 15 December 2005 no 1690 medical devices §1-5 d).

Clinical Evaluation: «The assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device when used as intended by the manufacturer» (MEDDEV 2.7.1 Rev.3 Clinical Evaluation: A guide for manufacturers and notified bodies.)