A medical device placed on the market or put into service must comply with the applicable regulations. The manufacturer must issue an EU declaration of conformity (DoC) and affix the CE marking to the device as proof of conformity.
The placing on the market of a device requires that the manufacturer has drawn up the required documentation based on which the manufacturer can demonstrate that the device meets the general safety and performance requirements. In order for a device to be considered a medical device, the manufacturer must demonstrate that the intended use of the device complies with the definitions given in the regulations.
Medical device economic operators must report economic operator information and the devices to Fimea in the CERE register or to Eudamed. See the Registrations page for further information.
Medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
The Regulation supplements the definition of in vitro diagnostic medical device compared to the definition used in the Directive (98/79/EC). With the Regulation, devices that determine predisposition to a medical condition or a disease or predict a response to treatment, for example, will also be covered by regulation.
According to Regulation (EU) 2017/746, in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, 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 on one or more of the following:
- concerning a physiological or pathological process or state;
- concerning congenital physical or mental impairments;
- concerning the predisposition to a medical condition or a disease;
- to determine the safety and compatibility with potential recipients;
- to predict treatment response or reactions; and
- to define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices.