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Classificazione dei Dispositivi Medici e dei Diagnostici in Vitro

Classification of Medical Devices and In Vitro Diagnostics

According to the definition of Regulation (EU) 2017/745 EU (MDR), a medical device is 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.

Medical devices are classified into four classes depending on the risk related to the device and on the type (and duration) of its contact with the human body:

  • Class I: Less critical devices, such as most of non-active and non-invasive devices (within class I, three subclasses can be identified: Class I sterile – those supplied in a sterile state; Class Im – those that perform a measurement function; Class Ir – including reusable surgical instruments)
  • Class IIa: Medium risk devices, such as certain non-active devices (either invasive or not) and active devices that interact with the body in a non-threatening manner.
  • Class IIb: 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 or animal derivatives and certain medical devices which act on the functions of vital organs.

Medical devices can be marketed in the EU provided that they are CE marked. The presence of the CE marking certifies that the product has been subjected to a conformity assessment procedure demonstrating to its compliance with the essential requirements of the relevant directive or regulation.

The CE marking for Medical Devices higher than Class I can be applied only after obtaining a CE certificate of conformity issued by Notified Bodies duly designated. The manufacturers may apply to any accredited Notified Body in Italy or in another EC country of their choice.

In Vitro Diagnostic Medical Devices

Legislative Decree no. 332/2000 defines in-vitro diagnostic medical devices (IVDs) as any medical device consisting of a reagent, a reactive product, a kit, an instrument, equipment or system, used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens from the human body, to provide information concerning a physiological or pathological state, or a disease or a congenital abnormality.

IVDs, 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 case of error in the performance for which they are intended.

IVDs are classified according to the risk associated with the type of analysis performed, and the type of reagents used to carry it out:

  • In vitro diagnostic medical devices covered by Annex II List A of the Legislative Decree no. 332/2000: High-risk for individuals and 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 risk for public health;
  • Devices for self-testing: any device intended by the manufacturer to be used at home by laymen, people with no expertise 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 be CE marked, to demonstrate their conformity with the relative legal provision, that in the case of other types of devices is applied following a manufacturer’s declaration, while for the other categories a CE certificate issued by a Notified Body is required.

According to Regulation (EU) 2017/746, not yet applicable, IVDs will be classified based on their intended use and on the risks that such use implies; four IVD classes are provided, ranging from A to D.

IVDs in Class A are the only ones not requiring a CE certificate issued by a Notified Body in order to be CE marked.

Di Renzo Regulatory Affairs has a special unit dedicated to regulatory activities for MDs and IVDs, and can assist companies in the classification of their products, and in the delicate shift from the Directive to the Regulation.

Foto di ronstik da Pixabay