The classification of a medical device is based largely on the risk associated with use of the device.
For a product to be classified as a medical device it must have an intended medical purpose and act primarily by physical means. Medical devices can be considered as Class I (lowest risk), IIa, IIb or III (highest risk).
Factors such as the invasiveness, the part of the body affected, and the duration of use all affect classification. Similarly, in-vitro diagnostic devices can be divided into as general category (low risk), List B and List A (high risk). Regulatory requirements (such as registration and route to CE marking) are heavily reliant on the classification of a device.
A manufacturer is responsible for the classification of their product. However, in certain situations it may be difficult to determine if a product qualifies as a medical device, and if so which class it falls under. In this case you may seek advice from the HPRA. The outcome of a formal classification request is generally available within 30 days, and there is an associated fee
Guidance on classification is available here:
How much does it cost?
An initial administration fee and annual fee is payable:
For further information on the classification of medical devices please see the following links:
- Medical Devices Directive 93/42/EEC, Annex IX
- In Vitro Diagnostic Directive 98/79/EC
- MEDDEV 2.4/1
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