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Authorized Representative
‘Authorized Representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;
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The EU Authorized Representative responsibilities
1.Documentation check
2.Registration check
3.Audit Support
4.Vigilance report
5.Compliance
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Who needs a European Authorized Representative
If you are:Located outside EU Companies outside EU can be out of EU law as they have no place of business there. Want to sell Medical Devices To receive authorization to sell your Medical Devices in EU you have to appoint one. It will be mandatory to get your CE certification from the Notified Body.
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Why choose Landlink as your European Authorized Representative?
● Our experienced consultants will review your Technical File, register your medical device, as required, and respond to any questions or concerns from the Competent Authorities.
● Our vast expertise with European regulations, registering hundreds of devices, facilitates a smooth and efficient registration process.
● We send frequent updates to all our Authorized Representation clients with important regulatory updates focused on Europe.
EUROPE CE
- HOME
- EUROPE CE
Shanghai Office, China
Room 1308, Baohua International Plaza West Guangzhong Road 555 Jingan District, Shanghai, P.R. China
TEL：+86 21-80317637
Email：info@landlink-health.com
Hangzhou Office,China
Room 1011, East Building, Building 5, Xintiandi Business Center, Gongshu District, Hangzhou
TEL：+8619357301533
Email：info@landlink-diag.com
USA Office
1337 Massachusetts Avenue #158 Arlington, MA 20476 USA
TEL：+1 8186589168
Email：info@landlink-healthcare.com
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