HPRA

Health Products Regulatory Authority

HPRA 🇮🇪 Ireland National Active
Home/ Competent Authorities/ Health Products Regulatory Authority

About

HPRA is Ireland's regulatory authority for health products including medical devices. It is responsible for market surveillance, vigilance, and clinical investigations under the EU MDR.

Regulatory Details

Regulatory FrameworkEU MDR 2017/745 (Irish implementation)
Device ClassificationClass I, Class IIa, Class IIb, Class III
Jurisdiction TypeNational
Country🇮🇪 Ireland
StatusActive

Online Resources

Contact Information

Country🇮🇪 Ireland
AddressKevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland
Phone+353-1-676-4971

Official Website

Need Regulatory Guidance?

Learn about device registration requirements for this market.

Get in Touch
Scroll to Top