Article 1- both medical devices and accessories shall hereinafter be termed devices
Article 2- definitions for medical device, accessory, device used for in vitro diagnosis, custom-made device, device intended for clinical investigation, manufacturer, intended purposes, placing on the market, putting into service
In vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, indented by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
concerning a physiological or pathological state
concerning a congenital abnormality
to determine the safety and compatibility with potential recipients
to monitor therapeutic measures
Specimen receptacles are considered to be in vitro diagnostic medical devices. “Specimen receptacles” are those devices whether vacuum- type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used in accordance with its intended purpose.
Manufacturer means the natural or legal person with responsibility for the design, manufacture, packaging and labeling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party
1) if a medical device is designed to administered a medicinal substance regulated by ordinance no. 152/1999 as amended by law no. 336/2002, this device will be ruled in accordance with present legislation without derogation from directive for medicinal products.
2) if a medical device consist of a device and a medicinal product, and it is designed to be administered in that combination only, this device will be treated as medicinal product and will be compliant with annex 1 of the present regulation exclusive for security and efficacy information
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