REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Ireland, devices are regulated by the Irish Health Products Regulatory Authority (HPRA).
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.
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 is required anywhere in the European Union.
ADDITIONAL INFORMATION: On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced the existing Directives. The new rules will only apply after a transitional period, namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
If you have a registered place of business in the Republic of Ireland (Manufacturers or local Authorized representatives) you must register with the HPRA if you:
- manufacture class I or custom made medical devices and place them on the market under your own name, or trading name(s),
- manufacture custom made active implantable medical devices and place them on the market under your own name, or trading name(s),
- manufacture in-vitro diagnostic medical devices and place them on the market under your own name, or trading name(s),
- fully refurbish class I devices, or label one or more ready-made devices, with a view to placing these on the market under your own name,
- place medical devices bearing the CE marking on the market, in a system or a procedure pack,
- sterilise, for the purpose of placing on the market, systems or procedure packs or other CE marked medical devices designed by the manufacturers to be sterilised before use,
- are the designated European authorised representative for a manufacturer who does not have a registered place of business in the European community, and who places on the market devices within the above-listed categories.
- Are a manufacturer or authorised representative relocating to Ireland as a result of Brexit.
