Medical Device Classification EU MDR

Medical Device Classification EU MDR proves that your device complies with the essential requirements of these CE directives; you need to affix a CE mark to it.  For that purpose, your product needs to go through the CE marking process. The direction of the latter depends on the class of your medical device and your choice of a conformity assessment route. 

Specific characteristics of your medical device will determine its class, and respectively how risky it is for the patients. For instance, characteristics such as intended use, invasiveness, and local vs. systemic effects. According to the Medical Device Classification EU MDR there are four classes of medical devices: Class I, IIa, IIb and III. 

Medical Device Classification EU MDR

The new Medical Device Classification EU MDR reflects the potential risk of harm that a medical device poses. Class I devices are seen as the lowest risk whereas Class III are deemed high-risk devices. Moreover, there is a new class of high-risk software that has been introduced with the MDR. Importantly, this includes stand-alone software (software that can work offline, or is a portable application). For example, an app that helps users to calculate drug doses would be a Class III medical device because the potential errors involved pose high-risks for the apps users.

Under the new regulation, it is important to understand the Medical Device Classification EU MDR rules – particularly what classification your medical device falls under – and the rules surrounding the classifications.

Medical Device Classification EU MDR are classified in accordance with 4 risk groups as follows:

Class I Medical Devices

Medical devices class I have the lowest perceived risk. The manufacturers of such devices can choose one out of three possible CE marking routes. In this regard, they should consider the following: if the medical device is sterile, e.g., a personal protection kit; if the medical device has measuring functions, e.g., stethoscope; and, if it’s not sterile, nor measuring, e.g., corrective glasses. 

Class IIa Medical Devices

Medical devices of class IIa could be such as surgical gloves, hearing aids, diagnostic ultrasound machines, etc. They usually constitute low to medium risk. Patients should use them for a short-term period, any less than 30 days. 

Class IIb Medical Devices

Here, we can include medical devices such as long-term corrective contact lenses, surgical lasers, defibrillators, and others. They are medium to high-risk devices, and patients may use them for a period longer than 30 days. In case your product is in class IIb, similar to the procedures in class IIa, you will need a Notified body to assess your technical documentation for compliance.

Class III Medical Devices

In that class, all medical devices have the highest risk possible, and permanent monitoring is required during their lifetime. There are specialized institutions responsible for conducting the products’ monitoring. Such devices are, for instance, cardiovascular catheters, aneurysm clips, hip-joint implants, prosthetic heart valves, and others.

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