Classification

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. 


HPRA Classification

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:

  1. Medical Devices Directive 93/42/EEC, Annex IX
  2. In Vitro Diagnostic Directive 98/79/EC
  3. MEDDEV 2.4/1

If you would like to know more information on classification of medical devices please contact the Human Products Authorisation and Registration Department at md.classification@hpra.ie.