According to the COUNCIL DIRECTIVE 93/42/EEC and as defined in the Legislative Decree 46/97, a medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
Medical devices are classified into four classes depending on complexity and the increasing risk.
- Class I: Less critical devices, such as most of those non-active and non-invasive.
- Class II a: Medium risk devices, such as certain non-active devices.
- Class II b: Medium / high risk devices, such as certain non active devices (invasive types) and active devices that interact with the body in a dangerous manner.
- Class III: High risk devices, such as most implantable devices, those containing medicines animal derivatives and certain medical devices which act on the functions vital organs.
Medical devices can be marketed in the EU after obtaining the CE certification that guarantees the product compliance to the essential requirements of the in-force Directive.
In Vitro Diagnostic Medical Devices
According to the COUNCIL DIRECTIVE 93/42/EEC and as defined in the Legislative Decree 46/97, 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, 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, or
- concerning a congenital abnormality, or
- to determine the safety and compatibility with potential recipients, or
- 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 for in vitro diagnostic examination;
In vitro diagnostic medical devices, for the purposes of conformity assessment, are classified into four categories based on the intended use indicated by the manufacturer and on the risk to public health and / or for the treatment of the patient, in the case of error in the performance for which they are intended:
- In vitro diagnostic medical devices covered by Annex II List A of the Legislative Decree no. 332/2000: High-risk for individual and to public health
- In vitro diagnostic medical devices covered by Annex II List B of the Legislative Decree no. 332/2000: High-risk for individual and / or moderate to public health
- Devices for self-testing: any device intended by the manufacturer to be used at home by layman, people not expert in diagnostic tests.
- Other types of devices: all other devices that do not belong in Annex II and are not intended for self-testing.
In order to market in vitro diagnostic medical devices in the EU, they should possess the CE certification demonstrating their compliance with the relative directive.
GB Pharma‘s activities:
- Verification of the conformity of the technical documentation and requirements;
- Notification of medical devices in the database of Ministry of Health;
- Notification of in vitro diagnostic devices to the Ministry of Health;
- Preparation of the technical dossier;
- Consultancy for obtaining the CE marking;
- Obtaining Certificates of Free Sale;
- Revision of advertising material and, if necessary, request for authorization.