Classification of medical devices is essential for proper handling of tools used in personal care.
Desire to further safeguard citizens’ health has prompted regulators to change the criteria governing classification. The adoption of the MDR (Medical Device Regulation) retains the four-class categorization, but introduces new, stricter rules to allocate these tools to the most appropriate risk band.
This change has led to the reclassification of many devices that were previously considered less dangerous than they actually were, causing a certain amount of inconvenience for industry professionals, while also ensuring greater public safety.
What characteristics are used to classify them?
According to Article 51 of the MDR, classification is based on two criteria: “intended use of the devices and risks involved”.
“Intended use” refers to the information that must be provided by the manufacturer specifying how to use the equipment correctly. In practice, this is the information found on the label, in package leaflets and in all informational material involved when promoting or selling products.
“Risks” are defined as “the combination of the probability of damage and the severity of that damage” (Art. 2 of the MDR).
Based on these characteristics and the rules set out in the MDR, medical equipment is placed into four classes: I, IIa, IIb and III.
Class I – low risk
Class I represents the lowest risk level.
This category includes non-invasive devices for temporary use, in other words instruments that “do not penetrate any part of the body, either through an orifice or through the skin”, and are used for less than 60 minutes. Adhesive bandages, crutches and corrective eyewear are examples of tools that are considered low-risk.
Given the limited potential hazard of these devices, it has been decided not to introduce additional supervisory personnel and to leave the manufacturer entirely responsible for inspections.
The manufacturer is therefore responsible for overseeing the necessary steps for marketing medical devices belonging to this class. Specifically, they must issue a Declaration of Conformity and affix the CE marking on them, allowing them to be marketed.
One step up is Class IIa, which represents a medium-low risk level.
This includes invasive devices for short-term use, i.e. instruments that “penetrate the body, including partially, through an orifice or body surface”, whose duration of use is between 60 minutes and 30 days. Needles and contact lenses are examples of devices that fall into this category.
Unlike the previous group, a manufacturer’s declaration is not sufficient to guarantee the instrument’s compliance; in this case, the involvement of another party, the Notified Body (ON), is required.
This institution is responsible for checking the technical documentation issued by the manufacturer to ensure that everything complies with the regulation. The documentation examined on each occasion for this purpose involves a single sample of devices chosen in a manner that is representative of the whole.
If the equipment is found to be compliant, the Notified Body issues the CE Certification, which allows the manufacturer to proceed with the Declaration of Conformity and to affix the CE marking.
Class IIb corresponds to a medium-high risk level.
Devices included in this group are defined as long-term invasive, i.e. with a duration of use of more than 30 days, or implantable invasive, i.e. partially or fully absorbed by the body. Two notable examples are incubators and X-ray machines.
Also in these cases, the Notified Body is required to assess compliance with the standard. In the case of implantable devices, the regulation obliges the manufacturer to also conduct a clinical investigation in order to have more data available and to make the assessment more accurate.
After this stage, the Declaration of Conformity can be issued and the CE marking can be obtained to market the product.
The last tier of the classification is class III, the high-risk class.
This category includes invasive devices that affect the functions of vital organs.
Equipment in this class must meet more stringent requirements. Manufacturers are obliged to carry out thorough clinical investigations to ascertain their safety and performance levels.
The MDR also requires the manufacturer to continue collecting clinical data after the devices are marketed, in order to ensure timely detection of any issues and take immediate corrective action.
Today, classification of medical devices has therefore become more complex than in the past, but these developments are beneficial to our health.
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