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Medical device classification
Medical devices are classified into four risk groups, according to the classification rules: I, IIa, IIb, and III (depending on the risk during use).
In Annex IX of EU Directive 93/42/EEC, the classification principles are laid down in great detail. The manufacturer is responsible for applying the classification rules, which are determined by the products' intended intent.
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Class I Devices: Low risk, non-invasive, everyday devices or appliances are classified as class I devices. The manufacturer is required to complete technical file for such devices.
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Class Is Devices: Class Is devices are comparable to class I devices. Additionally, they include sterile devices in this sub-group. These devices also require a technical file, as well as an application to a European Notified Body for manufacturing certification in accordance with sterility requirements.
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Class Im Devices: Similar low-risk measuring devices. The manufacturer must provide a technical file and be certified by a European Notified Body for manufacturing in accordance with metrology regulations.
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Class IIa Devices: Class IIa devices generally include low to medium risk and refer mainly to devices installed within the body in the short term. Class IIa devices are those which are installed within the body for only between 60 minutes and 30 days. Requirements are technical files and a conformity test carried out by a European Notified Body.
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Class IIb Devices: Slightly more complex than class IIa devices, class IIb devices are generally medium to high risk and will often be devices installed within the body for periods of 30 days or longer. Identical compliance route to class IIa devices with an added requirement of a device type examination by a Notified Body.
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Class III Devices: Class III devices are strictly high risk devices. The steps to approval here include a full quality assurance system audit, along with examination of both the device’s design and the device itself by a European Notified Body.