eu representative

EU Representative - European Authorized Services

EU Representative or European Authorized Representative will take on more risk & liability under the new MDR.

According to old MDD/IVD or as per new MDR /IVDR, manufactures do not have a physical location in Europe must appoint an Authorized Representative who is located within Europe.

It is required for European Medical Device Directive 93/42/EEC; Active Implantable medical devices 90/385/EEC and In Vitro Diagnostic Medical Device Directive 98/79/EC,  new Medical Device Directive (MDR) 2017/745. EU Rep will take on more risk & liability under the new MDR.

The EU Representatives performs certain duties under the & European Medical Devices Directives and acts as a legal interface between the Medical Device manufacturer and the EU Authorities.

Responsibilities of EU Representative

Article 11 of MDR 2017/745 details the important obligations & responsibilities of European Authorized Representatives. EU Representative, EU Rep, EC Representative, EC Rep, E.A.R all are synonyms of European Authorized Representative.

  1. There must be a written agreement signed and dated by the manufacturer and the EU Representative.
  2. The manufacturer shall enable the EU Representative to perform the below tasks if necessary:
  • Review Manufactures DOC and CE Certificate and confirm updated Technical File with the manufacturer; verify that an appropriate conformity assessment procedure has been carried out.
  • Make sure the Technical file and documentation are available for 10 years (medical devices) and 15 years (implantable devices) after the last device placed on the market.
  • Register on EUDAMED to obtain a single registration number (SRN)
  • Pass information to the competent authorities as and when requested or needed.
  • Make sure the manufacturer has complied with the Unique Device Identification (UDI) requirements.
  • Vigilance monitoring and immediately inform the manufacturer of complaints or reports on devices.
  • Terminate the contract if the manufacturer acts contrary to its obligations under the Regulation, and immediately inform the Notified Body.

  1. The manufacturer cannot delegate third persons to obligations, such as design and manufacture, risk analysis, clinical evaluation, technical documentation, declaration of conformity, or UDI compliance.
  1. Where the manufacturer is not established in a member state and has not complied with general obligations of the manufacturer (article 10), the A.R. shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.

Furthermore, the Article 15 of MDR 2017/745 lists obligations of EAR includes the necessity of one person responsible for regulatory compliance, who possesses the requisite expertise regarding the regulatory requirements for medical devices in the European Union.

Why the EU Representative Service is important for Medical Device?

  1. The EAR full address and contact details must be displayed on product labeling and/or instructions for use in the prominent area.
  2. The European Authorized Representative is responsible towards the European government, representing the manufacturer in all European regulatory affairs.
  3. The EAR (EC Rep) is obliged to submit medical device reports (MDR) on behalf of the manufacturer.
  4. A written signed dated agreement must be attached to the technical file. All duties and responsibilities of the E.A.R should be clearly defined in the agreement.
  5. The EC representative must at all times be available to interact between the manufacturer, the European authorities and the notified body.

EAR Annual Service Fees

  1. Class l: 600 Euros Annual
  2. Class ls / lm / IIa: 700 Euros Annual
  3. Class IIb: 850 Euros Annual
  4. Class III: 1000 Euros Annual
  5. Free Sale Certificate: 2500 Euros / GMDN Code /Country (60 working days).
  6. E.A.R Certificate Attestation from Chamber of commerce: 150 Euros

Timeline for E.A.R Agreement Drafting and Signing: 7-10 working days

If you have multiple devices and need a customized quote or wish to know more about European authorized representative role under the new MDR Regulation, Please write to us. or fill the request for quote below:

Request for Quote (RFQ), Click here.

More Information about European Free Sale Certificate (FSC). Click here.

Recent Client Testimonial...

EU Representative Reviewed by Sam James in . Wonderful Team and Support!. I am happy to recommend I 3 Consuting to others looking for European Authorized Representative Services. Rating: 4.9

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