Principal definitions

Medical devices (according to Article 3 of the Medical Devices Act, Official Gazette no. 76/13) are instruments, apparatuses, appliances, software, materials or other articles for human use that are used alone or in combination, including the software for diagnostic or therapeutic purposes, and that are necessary for their proper use. Medical devices do not achieve their principle intended action in or on the human body by pharmacological, immunological or metabolic means, although their action may be assisted by such means.

They are intended for:

diagnosis, prevention, monitoring, treatment or alleviation of disease
diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap
investigation, replacement or modification of the anatomy or of a physiological process
control of conception.

The following are also considered medical devices:

Active medical devices - medical devices relying for their functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.

Active implantable medical devices - active medical devices intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and to remain after the procedure.

Custom-made devices - devices specifically made in accordance with a duly qualified medical practitioner’s or dental practitioner’s written prescription which gives, under his responsibility, specific design characteristics and are intended for the sole use of a particular patient.

Medical devices intended for clinical investigation - medical devices used as the subject of investigation or as additional equipment in the investigation of a medicinal product.

Accessories - devices that are not medical devices, but are intended specifically by their manufacturer to be used together with a medical device to enable the medical device to be used in accordance with its purpose intended by the manufacturer.

According to the Medical Devices Act (Official Gazette no. 76/13), medical devices include in vitro diagnostic medical devices including reagents, reagent products, calibrators, control materials, kits, instruments, apparatuses, equipment or systems, whether used alone or in combination, intended 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.

In vitro diagnostic medical devices also include:

Specimen receptacles - devices, whether vacuum-type or not, specifically intended by their manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
Medical devices for self-testing - in vitro diagnostic medical devices intended by the manufacturer for home use.
Medical devices for performance evaluation - in vitro diagnostic medical devices intended for evaluation studies in a laboratory or in other appropriate environments.
Accessories - devices that are not in vitro diagnostic medical devices, but are intended specifically by their manufacturer to be used together with an in vitro diagnostic medical device to enable the in vitro diagnostic medical device to be used in accordance with its purpose intended by the manufacturer.

Medical devices are grouped according to the level of risk, taking into consideration their purpose and duration of contact with the user and whether they are active or even invasive devices.

Class I - low risk for users
Class Im - Class I with a measurement function
Class Is - Class I sterile
Class IIa - medium risk for users
Class IIb - high risk for users
Class III - highest risk for users

In vitro diagnostic medical devices are classified as follows:

those listed in List A of Annex II
those listed in List B of Annex II
in vitro diagnostic medical devices for self-testing or performance evaluation that are not listed in Annex II
other in vitro diagnostic medical devices