Device - Classification rules and examples

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All devices that pass through the classification system must
1. meet the essential requirements irrespective of the class of the device
2. be subject to reporting requirements under the medical device vigilance system, and
3. be CE marked - except custom-made devices and devices intended for clinical investigation.

Medical devices are classified by answering a set of rules according to its properties, function and intended purpose.
There are 4 broad groups within the rules:

Rules 1-4 for non-invasive devices
Rules 5-8 for invasive devices
Rules 9-12 additional rules applicable to active devices
Rules 13-18 miscellaneous rules for products which should have a higher classification than they might otherwise be assigned.

Each device is taken through a set of rules, based on potential hazards related to its use and possible failure, taking into account its duration of use, location of use, level of invasiveness, and whether it is active or non-active. The purpose of the classification system is to allow the strictest controls to be applied to those devices which present the greatest risk to health or safety of the patient. Class 1 devices are of low risk, Class IIa for low to medium risk, Class IIb for medium to high risk and Class III for high risk.

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Classification definitions

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