HPRA
Competent authority · Ireland · Dublin
A national competent authority for medical devices under the EU MDR/IVDR — market surveillance, vigilance and EUDAMED registration oversight.
A national body that oversees the application of EU medical-device regulation in its country — market surveillance, vigilance, economic-operator validation and EUDAMED registration oversight, under MDR Articles 101–108.
Explore every authority and economic operator registered in Ireland.
A national body that oversees the application of EU medical-device regulation in its country — surveillance, vigilance, and registration oversight.
No — that's a notified body. A competent authority supervises the market; it does not issue device certificates.
Sourced directly from EUDAMED. This record was last updated Jun 29, 2026.
Capability matrix published by EUDAMED for this authority.
Operators whose registration was validated by this authority.
| Operator | Role | SRN | Country |
|---|---|---|---|
| Infusion Healthcare Ltd | Importer | IE-IM-000020339 | IE |
| 1073849 Ontario Limited | Manufacturer | US-MF-000020857 | US |
| 151 Products (Ireland) | Manufacturer | IE-MF-000035377 | IE |
| 4S HBM Ltd | Importer | IE-IM-000055244 | IE |
| 4S HBM Ltd | Authorised representative | IE-AR-000031279 | IE |
| 6:8 Medical Solutions | Manufacturer | US-MF-000048390 | US |