| Regulatory Authority | Health Products Regulatory Authority (HPRA) |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | Medical Devices Regulation | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | (EU) 2017/746 | Click Here |
| Device Classification Guidelines |
The MDCG has published guidance on the Click Here |
| Registration Process | Medical Devices Registration | Click Here |
| Registration Timeline | For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Conformity Assessment Route |
In Ireland, the conformity assessment route for medical devices follows the European Union (EU) Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, as Ireland is an EU member state. |
| Technical Documentation Format |
The Technical Documentation for medical devices in Ireland follow the EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. | Click Here |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Irish and English Language |
| Labeling Requirements |
The labeling requirements for medical devices in Ireland follow the EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. Since Ireland is an EU member state. | Click Here |
| Clinical Trials Information |
Guide to Clinical Investigations Carried Out in Ireland | Click Here |
| Fees for Submission |
The HPRA charges fees for:
|
| Certificate of Free Sale |
A certificate of free sale is a document used in the registration of a device in a third country (i.e. countries outside the EU). It indicates that a device is compliant with EU law. | Click Here |
| Adverse Event Reporting Form | Download |
| Additional Information | The Economic operators such as Manufacturers, Custom made device, manufacturers, Manufacturing facilities, Authorised representatives, System and procedure pack producers, Importers, Distributors and Health institutions |