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European Authorized Representative

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

european authorized representative

EU REPRESENTATIVE

4 Working Days

EU REGISTRATION

10 Working Days

FREE SALE CERTIFICATE

30 Working Days

Responsibilities of EU Representative 

According to Article II of the EU MDR and IVDR, the following are the roles and responsibilities of the European Authorized Representative.

 

  • Provide a registered address in the EU to be mentioned on the product packaging
  • Keep the updated technical documentation available for inspection by the competent authorities
  • Represent the manufacturer in front of the European Commission, NB’s and the users
  • Device registration and EU Free Sale Certificates
  • Take care of incidents reported by the healthcare professionals, patients, and users
  • Safeguard the compliance with regulatory news and updates
  • Check the registration of the importer, manufacturer with the EU and update accordingly
  • EU Representative consult and continuously support the manufacturer
  • Terminate the mandate if the manufacturer acts contrary to MDR/IVDR obligations
  • Review and guide on PMS, PMCF and PSUR requirements, if required

EAR Agreement

The European Authorized Representative (EAR) is represented on the medical device label with logo, as seen below. Along with the logo, the EAR name, address, and contact information must be printed on the Declaration of Conformity (DOC), Technical Documentation, and in the Instructions for Use (IFU). To appoint an EU Rep EC Rep, the manufacturer must sign contract outlining each party’s rights and responsibilities, as well as the general way of collaboration and costs.

 

Formalities for changing and existing EC Rep

 

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 EC Rep, and the incoming EU 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 EU Representative.

MDR 2017/745 

Class I : 850 Euros
Class I : 950 Euros ( Sterile / Measuring / Reusable)
Class IIa : 1050 Euros
Class IIb : 1150 Euros
Class III : 1350 Euros
EU Registration : 500 Euros per device

IVDR 2017/746 

Class A : 950 Euros
Class B : 1150 Euros
Class C : 1350 Euros
Class D : 1450 Euros
EU Registration : 500 Euros per device

Benefits of working with I3CGLOBAL and its associates

♦  ISO 27001:2013 Certified data security system. We safeguard the confidentiality of technical documents and other information you provide to us.

♦  When judgments must be made that go against the interests of an importer/distributor, we operate in your best interests.

♦  While distributors and corporate branch offices may have other priorities, we react to inquiries from authorities quickly and effectively.

♦  Unlike other legal firms and trading organizations, we are regulatory consultants for medical devices. We provide quality and compliance knowledge in countries outside of the EU, such as the United Kingdom and the United States, ensuring that manufacturers obtain good value for money throughout the EAR process and other significant markets.

 

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EU Registration

Yes, it is required at the port of entry. The EU Authorized Representative has the authority to register non-EU manufacturers and medical devices with EU authorities. Will complete the EU Registration in the nation where the EC Rep is based. Only after the mutual signature of a European Authorized Service Agreement and submission of signed Declarations of Conformity (DOC) and Device Test Reports can EU Registration be filed for. The average time to register for the EU is two weeks.

EU Registration process

 

EU Representative

EUDAMED Registration

EUDAMED registration will improve openness for the general public and healthcare professionals, as well as the coordination of information on medical devices and IVDs on the EU market.  Read More>>

 

EUDAMED Registration

 

European Free Sale Certificate (FSC)

 

The European Free Sale Certificate (FSC) is proof that medical equipment can be lawfully sold or distributed freely and without limitation with the consent of the country’s regulatory authorities. Read More >>

 

Countries Issues European Free Sale Certificate (FSC)

 

EC Representative / EU Rep Logo Display

 

All Non European manufactures / Exporters must display European Authorized Representative Name and contact Information with appropriate Logo along with manufacturer logo and information.

 

EC Rep Symbol
EC Rep Symbol