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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