European Authorized Representative (EAR)
Non-EU medical device manufacturers must designate a European Authorized Representative (EAR) to place their devices on the EU market under EU MDR 2017/745.
Liberty Management GroupSince 2009
Under EU MDR 2017/745 (Medical Device Regulation), non-EU manufacturers must designate an EU Authorized Representative (EAR) to place their devices on the European market.
The EAR acts as the manufacturer's representative in Europe and is registered with the relevant national competent authority.
- Mandatory for all non-EU manufacturers under EU MDR 2017/745
- EAR must be registered with the national competent authority
- EAR is responsible for the manufacturer's regulatory obligations in the EU
- EAR information must appear on the device label
- LMG provides guidance on EU MDR compliance alongside FDA consulting
Contact LMG for guidance on EU Authorized Representative requirements alongside FDA registration.
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