Regulatory Information

The HPRA is responsible for the regulation of medical devices on the Irish market and is designated as Competent Authority (CA) for medical devices in Ireland.

This section of the HPRA website includes information for the medical devices industry. Explanatory information and relevant HPRA guides and forms are provided as appropriate under each topic as well as links to relevant external sources.

Information about notified bodies for medical devices is also included.

The HPRA encourages communication with the medical device sector. Should you have specific queries please address them to the Human Products Authorisation and Registration Department of the HPRA who will endeavour to be of assistance. Please contact us at devices@hpra.ie

Medical Devices Legislation

There are three types of medical devices outlined in the legislation. They are as follows:

• general medical devices 
• active implantable medical devices 
• in-vitro diagnostic medical device. 

Medical devices are divided into classes dependent on risk which can be low, medium and high risk.

About Medical Devices

The term 'medical device' covers all products used in healthcare for the diagnosis, prevention, monitoring or treatment of an illness or handicap and which achieves its principal intended action by physical means.  

The range of products is very wide and includes many thousands of items used each and every day by healthcare providers and patients.

It includes: contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames or other assistive technology products; pregnancy tests, blood glucose monitors and pacemakers  

A medicine may be incorporated in some devices and have an ancillary effect. An example of this type of medical devices is a drug eluting coronary stents.

The scope of medical device regulation also includes in vitro diagnostic (IVD) medical devices. An IVD medical device includes any medical device (such as a reagent, reagent product, calibrator, control material, instrument, apparatus) that is used alone or in combination and that is intended by the manufacturer to be used in vitro to provide information on, for example, a physiological or pathological state or to monitor therapeutic measures. These include pregnancy test kits, urinalysis test strips and specimen receptacles (such as blood collection tubes).

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