eu representative

EU Authorized Representative (Medical Devices)


EU Representative performs certain important duties under new Medical Device Regulation and old European Medical Devices Directives.

EU Representative acts as a legal interface between the Medical Device manufacturer and the European Union Authorities.

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

It is required for CE Certification under medical device directive 93/42/EEC; Active Implantable medical devices 90/385/EEC and In vitro Diagnostic Medical Device Directive 98/79/EC, and also the new Medical Device Regulation (MDR) 2017/745 and In Vitro-Diagnostic Medical Device (IVDR) 2017/746.

EC Representative will take on more risk & liability under the new MDR.

GDPR and Medical Device Regulation (EU) 2017/745 (MDR)

MDR Annex I General Safety and Performance Requirement 14.2 mentioned interaction between software and the IT environment in which a software medical device operates and collect data.

Also in Article 110 of the MDR requires the application of 95/46/EC Directive on the Protection of Individuals with regard to the processing of individual data and transfer of such health data.

Responsibilities of European Authorized Representative (EAR)

Article 11 of MDR 2017/745 details the important obligations & responsibilities of European Authorized Representatives.

  1. There must be a written agreement signed and dated by the manufacturer and the EU Representative.
  2. The manufacturer shall enable the 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 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 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 EU Representative Service a must for Non EU Manufactures?

  1. The EAR full address and contact details must be displayed on product labelling and/or instructions for use in the prominent area.
  2. 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.

EU Representative

Medical Device Competent Authority registration.

All medical devices sold in Europe must be registered with Competent Authority. Registration must be done with the competent authority belongs to your locality. All non European manufactures must register with competent authority where your European Authorized Representative ( EU / EC Representative) is based.

Class 1 device can be registered after signing declaration of Conformity (DOC) and CE Mark on device, whereas Class Is, Ir, Im, IIa, IIb, or III devices that are placed on their markets after receipt of CE Certificate from Notified Body.

EAR Annual Service Fees (MDD / IVD Only)

  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. Establishment and Device Registration with Competent Authority: 150 Euros (One time Fees)
  7. E.A.R Certificate Attestation from Chamber of commerce: 150 Euros (One time Fees)

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 request for quote

Consider his/her consent! GDPR is to impose strict actions in relation to using a medical device for accessing or managing sensitive patient data. If the patient is using the medical device there must be a completed consent form from the patients must be on record.

Standalone software manufactures and or medical devices manufactures that process human personal data and place their products on the European Union market.

EC Representative is from Germany. German Competent Authority is DIMDI.

Yes, DIMDI Registration a must for Free Sale Certificate. FSC can be applied through European Authorized Representative (E.A.R)

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