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European Authorized Representative for Medical Device

According to the EU MDR 2017/745 and EU IVDR 2017/746, European Authorized Representative is mandatory for Non-European manufacturers wishing to sell the medical device and (IVDs) on the European market. EC Rep is a natural or one who is legalized and established within the EU, who has received and accepted a written mandate or decree from the manufacturer located outside of the EU.

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EC Representative

Best, Fast & Economic European Authorized Representative Service for Non EU Medical Device manufactures and exporters.

EU Registration

EU Registration is mandatory for EU Port of entry Permission.  MDR /IVDR manufacturers must complete EUDAMED Registration.

Free Sale Certificate

We organize European Free Sale Certificate which is commonly asked by Asian and Middle East country device registrations.

European Authorized Representative Roles and Responsibilities
as per Article II of EU MDR and IVDR:

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  • Provide a registered address in the EU to be mentioned on the product packaging;
  • Keep the updated EU DOC, the Technical Documentation and certificates permanently available at the registered address for inspection by the competent authorities;
  • Maintain constant availability to represent the manufacturer in front of the European Commission, EU authorities, EU NB’s and the EU users;
  • Complete applications on behalf of the manufacturer for Device registration and EU Free Sale Certificates etc.;
  • Take care of any incidents reported (vigilance reporting) by the healthcare professionals, patients, and users and immediately inform the manufacturer;
  • Safeguard the compliance with regulatory news and updates;
  • Check the registration of the importer, of the manufacturer, of the products and of themselves with the EU. It needs to be checked that those are updated;
  • Consult and continuously support the manufacturer;
  • Terminate the mandate if the manufacturer acts contrary to its obligations laid out in the EU MDR/IVDR

Changing an EC Rep for Medical Device

As per Article 12 of the EU MDR and the EU IVDR, the detailed arrangements for a change of E.A.R should be clearly defined in an agreement between the manufacturer, where practicable, the outgoing authorized representative, and the incoming authorized representative. The agreement should address at least the following aspects:

 

  • The dates of termination of the mandate of the departing E.A.R and date of the beginning of the mandate of the incoming E.A.R;
  • The dates until which the departing European Authorized Representative may be specified in the information supplied by the manufacturer, including any promotional materials;
  • The hand-over of documents, including confidentiality aspects and property rights;
  • The responsibilities of the departing European Authorized Representative after the end of the mandate to forward to the manufacturer or incoming EC Rep regarding any complaints or reports from healthcare professionals and users about suspected incidents or adverse events related to a medical device/IVD for which it had been designated as the authorized EC Representative.

European Authorized Representative

Why I3CGLOBAL is the best for EU Registration?

EC Representative Fees

We are Regulatory Consultants and European Authorized Representative for Medical Devices and IVDs. Therefore, we understand your device better than any other professionals serving as an EAR. Our services are economic and faster. Drafting and signing will not take more than 10 days.

EC Rep Quote Request for Medical Device

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    Annual EAR Service MDD


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    Annual EAR Service IVD


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    Model addition Fees


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    EU Registartion


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    Important Information's for Non-European Manufactures and Exporters