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European Authorized Representative for Medical Device - EAR

According to European law for medical devices, companies that do not have a physical location in Europe must appoint a European Authorized Representative or so called EU Representative who is located within Europe. It is required for European Medical Devices Directives (Medical Device Directive 93/42/EEC; Active Implantable Medical Devices 90/385/EEC; and, In Vitro Diagnostic Medical Device Directive 98/79/EEC).
A European Authorized Representative or EU Representative is the main contact for the European Commission and the National Competent Authorities. After appointing European Authorized Representative he/she or there company will effectively ensure your company’s compliance with the European Regulatory reporting requirements as per the tasks required in the applicable directives.
The European Authorized Representative performs certain duties under the European Medical Devices Directives and acts as a legal interface between the Medical Device manufacturer and the EU Authorities. European Authorized  Representative or EC Representative or EU Representative cannot modify the product on his own initiative in order to bring it into line with the applicable directives. 
The Aspects of a European Authorized Representative

  1. The EU Representative or EC Representative name, Full address must be displayed on product labeling (and/or) instructions for use in the prominent area.
  2. The European Authorized Representative / EC Representative is responsible towards the European Government, representing the manufacturer in all European Regulatory Affairs.
  3. The European Authorized Representative / EU Representative is obliged to submit Medical Device Reports (MDRs) on behalf of the manufacturer.
  4. The EU Representative / EC Representative / EAR must be appointed in writing with validity date and date of signing the agreement. All duties and responsibilities should be clearly defined and assigned.
  5. The Authorized Representative must at all times be available to interact between the manufacturer, the European Authorities and the notified body.

I 3 CONSULTING provides EU Representative / EC Representative service from our German office in Dusseldrof.
We offer EAR / EU Representative / EC Representative service in 4 working days at very economic annual fees.

Annual Fees
Class l – 550 Euros/ year
Class ls/lm/lla – 650 Euros/ Year
Class llb – 850 Euros /Year
Class lll – 1000 Euros /Year
Free Sale Certificate Fees – 2500 Euros / UMDNS Code / Country with Embassy attestitaion in 60 working days.

We also provide EU Representative Certificate signed by Dusseldorf Chamber of commerce with an addition Fees of 100 Euros

Need a Quote? Please write to enquiry@i3cglobal.com with device GMDN/UMDNS codes or Device risk class and Intended use.

To know more about Certificate of Marketability / Free Sales Certificate click here>>

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