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Device classification is one of the initial activities in the lifecycle of your product. This step informs the extent to which a specific regulation will apply to your device. This article will focus on the classification according to Regulation EU 2017/745, namely the Medical Device Regulation (MDR).
Device classification adopts a risk-based approach and categorizes devices depending on their intended use. Ultimately, devices that pose a low risk require less scrutiny than their counterparts that present a high risk. Since risk is generally seen as a subjective notion, ISO 14971:2019 provides a standardized methodology of analysing, evaluating and managing medical device risk.
According to the MDR, there are four risk classes:
Class I - low risk. Further, Class I devices can be broken down into the following categories:
class Ir - for re-usable devices;
class Im - for measuring devices;
class Is - for sterile devices.
Class IIa - moderate risk
Class IIb - moderately high risk
Class III - highest risk
In its 9th Annex, the regulation lays out the criteria and requirements for classifying a medical device. Here are some factors that should be considered when determining classification:
what is the duration of use of the device?
is the device invasive or non-invasive?
is the device implantable?
is the device connected to a source of energy?
does the device emit any form of radiation, whether intended or not?
does the device incorporate chemical and/or biological substances?
While the regulation's classification rules are comprehensive (and very descriptive), navigating through them can be time-consuming, especially as the number of products to classify increases. What's more, the regulation states that when multiple rules are applicable, which is often the case, the device classification is based on the rule that results in the highest classification.
Infomed Consulting has developed a smart and simple classification tool that classifies your device. The tool is a Google Sheets questionnaire divided into 12 sections (you only answer the sections applicable to your device). Once you've completed the questionnaire, you can immediately see the classification of your device, as well as the applicable rule(s).
Visit our online store to access this tool and contact us for any queries.