A medical device, as defined in the Legislative Decree 46/97, is any instrument, apparatus, appliance, material or other article, whether used alone or in combination (including software necessary for its correct functioning) and intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease; for diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; for investigation, replacement or modification of the anatomy or of a physiological process; for conception intervention, for which the product does not achieve its principal intended action in or on the human body, by pharmacological or immunological means via a metabolic process, 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 (within class 1 two subclasses can be identified: Class I sterile – those supplied in a sterile state – and Class I m – those that perform a measurement function).
- Class IIa: Medium risk devices, such as certain non-activedevices(invasive active devicesthat interact with thebodyin a non-threatening manner.
- Class IIb: Medium / high risk devices, such as certain non active devices(invasive types) andactive devicesthat interactwith the body ina dangerous manner.
- Class III: High risk devices, such as most implantable devices, those containingmedicinesanimal derivativesandcertain medical deviceswhich act on thefunctionsvital organs.
Medical devices can be be marketed in the EU after obtaining the CE certification. This certificationguarantees that the product has been subjected to a conformity assessment procedure that attests to its compliance with the essential requirements of the relative Directive.
The CE certification for Medical Devices higher than Class I is issued by Notified Bodies accredited for the certification of specific types of medical devices and for specific conformity marking procedures. The manufacturer may apply to any accredited Notified Body in Italy or in another EC country of his choice.
All medical devices marketed in Italy must be registered in the database of the Ministry of Health, as required by the Ministerial Decree of December 21, 2009.
In Vitro Diagnostic Medical Devices
The Legislative Decree 332/2000 defines In-Vitro Diagnostic Medical Devices as any medical device consisting of a reagent, a reactive product, a calibrator, control material, a kit, an instrument, apparatus, equipment or system intended by the manufacturer to be used in vitro for the examination of specimens from the human body, including blood and tissue donations, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or allowing for the measurement of the safety and compatibility with potential recipients, or allowing for the monitoring of therapeutic measures.
Specimen containers are considered to be in vitro diagnostic medical devices.
Specimen containers are devices, whether vacuum-type or not, specifically intended by their manufacturers to directly collect a specimen from the human body and store it for the purpose of an 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:
IVD medical devices are classified according to the risk associated with the type of analysis performed and the type of reagents used to carry this out:
- 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.
These products make up the vast majority of devices and do not pose a direct risk to the persons tested, as they are mainly used by adequately prepared professionals. Moreover, the results of the analysis, obtained with this type of reagents, must be confirmed by other means.
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.
Following the entry into force of Eudamed on the 01/05/2011 there is a continuing obligation to notify the Ministry of Health of data which allows for the identification of devices referred to in Annex II and devices for self-testing placed on the market or put into service within the Italian territory, as provided for in Article 10, paragraph 2 of Legislative Decree 332/2000.