Alims ALiMS Vlada Republike Srbije
ALiMS
DEFINITION AND DIVISION OF MEDICAL DEVICES
A Medical Device represents:

a) any instrument, apparatus or product used on humans and animals, either independently or in combination, including the software for their proper use.

detailed

b) a diagnostic medical device in vitro, involving a reagent, a reagent product, control and calibration material, a kit, an instrument, an apparatus, equipment or a system used independently or under combination intended for tests under in vitro conditions, including blood and transplant tissues obtained from human organisms.

detailed

v) an auxiliary device that does not comply with the definition of medical device and indicates a product which - in combination with the medical device - enables its functioning according to its purpose.;

g) a medical device manufactured to order for a specific user (product made in accordance with a written specification by an expert, the product itself having special characteristics);

d) a medical device intended for clinical trials (devices used by health-care workers as part of clinical trials).