Medical Devices and Risk Classes: An Overview

All Medical Devices on the market are grouped into four risk classes:
Class I Class IIa Class IIb Class III
Medical Device e Classi di rischio

The classification criterion is fundamentally based on the complexity of the device and on the potential risk that it represents for the patient in the event of a malfunction: Class I devices, which can be produced for the external help of the patient, are low-critical and low-risk devices (wheelchairs, stethoscopes, etc.); those of classes IIa and IIb are medium and medium/high risk devices (many electromedical devices belong to these two categories); high-risk devices (for example, vascular catheters) are classified in Class III.

The complexity and potential risk of Medicsl Devices (and therefore their belonging to a certain class of risk) are determined by three elements: the level of invasiveness, the possible dependence on an energy source and the duration of the contact time with the patient’s body.

A Medical Device is non-invasive if it does not penetrate into any part of the body, either through the skin or through the orifices (for example, eyeglasses or crutches). On the contrary, all devices that penetrate even partially are considered invasive (regardless of how they are inserted into the patient’s body).

The category of invasive Medical Devices is in turn divided into three subgroups: 

  • Invasive devices that penetrate through the body’s orifices
  • Surgical invasive devices, which penetrate through the body surface both in the context of surgery and outside of it
  • Implantable devices, which are inserted into the human body surgically and are then intended to remain there after surgery (for example, Peacemakers)

Devices partially introduced into the body through surgery and intended to remain in place for a period of at least thirty days after the operation are also considered implantable.

As regards the criterion of the duration of the contact time, there are Medical Devices intended to:

  • Temporary use: the expected continuous duration is less than 60 minutes
  • Short-term use: the expected continuous duration is not more than 30 days
  • Long-term use: continuous duration is more than 30 days

The last distinctive feature, based on dependence or independence from energy, divides the Medical Devices into active and non-active. Active Medical Devices are those whose functioning is necessarily linked to a source of energy – different from that generated by the human body or the force of gravity – and which act by converting that energy (electrosurgery, surgical robot, etc.).

The compliance of the product with the directives – and the consequent CE marking – is necessary for the sale of the device within the European Union. 

All Medical Devices marketed in Italy must be registered in the database of the Ministry of Health as required by the D.M. of 21 December 2009.

Medics diagnostic models are three-dimensional and patient-specific anatomical reconstructions that allow a risk-free manipulation: based on these peculiarities (custom made realization and no risks for the patient), our (virtual and physical) anatomical replicas have been classified by Directive 43/92 and by MDR as Class I customized devices.

Instead, our surgical guides have been included in the category of Class IIa customized devices, according to their specific characteristics: tailor-made surgical instruments with which the surgeon can perform gestures directly on the patient (osteotomies, holes and more) in a safe and guided way.

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