How is the classification of medical devices according to MDR carried out?

Medical devices are subject to the risk classes defined in the Medical Device Regulation (MDR). According to the Regulation (EU) 2017/745 (MDR), classification is made into four classes I, IIa, IIb and III (low to high risk in ascending order). But what exactly is the classification based on? And who has to follow it?

What counts for the time being, however, is the question: Is the product really a medical device? Or is it a non-medical device, accessory or even in vitro diagnostic device (IVD)? The answer around the definition can be found in Article 2 of the MDR.

Accordingly, a medical device is an instrument, apparatus, appliance, software, implant, reagent, material […] which, according to the manufacturer, is intended for human use and is intended to fulfil, alone or in combination, one or more […] specific medical purposes. Source (in german)

Classification of in vitro diagnostic medical devices (IVD) – how is classification done?

What counts as in vitro diagnostics (IVD) and into which risk classes are IVDs classified? Read more in our blog post.

Once it has been determined that the product is a medical device according to the MDR, the next step is to determine the labelling, instructions for use and promotional materials as well as the actual intended purpose. Manufacturers determine the intended purpose individually for each product. For this purpose, a definition for medical devices according to Article 2 of the MDR must be fulfilled.

Based on this intended purpose, the classification of the medical device into a risk class follows. For the classification of the product into the respective product class, the regulation provides a total of 22 rules in Annex VIII of the MDR.

The manufacturer of the medical device or their authorised representative is responsible for the risk classification. Not quite so simple: The Federal Institute for Drugs and Medical Devices (german: BfArM) rules out a blanket classification into risk classes based on product groups, as the classification is always based on the intended purpose and individual information provided by the manufacturer.

Good to know

If a medical device is used in combination with another device, a separate classification must be made in each case. Accessories for a medical device are also classified separately.

Risk classification in a few steps

To provide optimal support in classification according to the medical device regulation (MDR Article 51 (1)), the BAYOOSOFT Risk Manager fully integrates the functionality for classifying the medical device into categories I, IIa, IIb or III in the validated approval accelerator. Based on an interactive questionnaire, you are guided through the classification process and can issue the result as a report.

This provides you with an initial reference for classifying your medical device. You then only need to give a justification for the classification, considering the intended purpose and stating the applied rules.

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Get to know the BAYOOSOFT Risk Manager

The efficient way to technical documentation: BAYOOSOFT Risk Manager supports you in the creation of technical documentation for medical devices and in vitro diagnostics. All relevant information is recorded in a clearly structured environment, stored centrally in an audit-proof manner and linked dynamically in a fine-granular manner. This automatically avoids redundant data storage. Reports are generated with the most up-to-date data at the touch of a button.

Would you like to get to know the BAYOOSOFT Risk Manager? Then take advantage of our 30-day free TRIAL or visit one of the upcoming online product presentations. You can find an overview of upcoming topics here.

How is the classification of medical devices according to MDR carried out?

Risk classification in a few steps

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