Ireland
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. Additional registration with the Health Products Regulatory Authority (HPRA) is required if a manufacturer or their authorized representative has their registered place of business in Ireland.  

CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV.

TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.

LICENSE VALIDITY: Licenses issued in the EU are valid for five years.

AUTHORIZED REPRESENTATIVE: An authorized representative anywhere in the European Union is required.

ADDITIONAL INFORMATION: The Medical Device Directive is due to be changed in 2015.

Last updated on March 24 2015.



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