European Authorized Representative

European Authorized Representative (EU & EC)

European Authorized Representative (EU Rep or EC Rep), according to European law for medical devices, companies that do not have a physical location in Europe must appoint a European Authorized 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/EC) and new Medical Device Directive(MDR) 2017/745.

The EC or EU 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.

Responsibilities of European Authorized Representative under new Medical Device Regulation (MDR).

Article 11 of MDR 2017/745 details the important obligations and responsibilities of European Authorized Representatives service:

  1. There must be a written agreement signed and dated by the manufacturer and the EU Representative /EC Representative.

  2. The manufacturer shall enable the EC Representative to perform the below tasks if necessary:

  • Review Manufactures DOC and CE Certificate and confirm updated Technical File with manufacturer; verify that an appropriate conformity assessment procedure has been carried out;
  • Make sure the Technical file / technical documentation are available for 10 years (medical devices) and 15 years (implantable devices) after the last device placed on 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 EC /EU Representative 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.

EU Representative will take on more risk and liability under the new MDR. EU/EC Rep will be liable for defective medical devices.

Why EC or EU Representative important for Medical Device CE Marking?

1.   The EU Representative or EC Representative Name, Full address and Contact must be displayed on product labeling and/or instructions for use in the prominent area.

2.   The EU Representative or EC Representative is responsible towards the European Government, representing the manufacturer in all European Regulatory Affairs.

3.   The Representative is obliged to submit Medical Device Reports (MDRs) 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 European Authorized Representative must at all times be available to interact between the manufacturer, the European Authorities and the notified body.

European Authorized Representative (E.A.R) Annual Fee

1. Class l : 550 Euros Annual

2. Class ls/lm/lla : 750 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

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