EU Authorized Representative: Roles & Responsibilities

An EU authorized representative is a legal entity in EU that non-EU manufacturers must appoint to act on their behalf. The authorised representative serves as the official contact point with EU authorities. It verifies that technical documentation and declarations of conformity are in place. Additionally, it ensures vigilance and post-market surveillance obligations are met and makes sure their details appear on device labeling. Importantly, the representative shares legal liability with the manufacturer for defective or non-compliant devices. Hence, they play a critical role in regulatory compliance and market access in the EU.

What is EU authorized representative?

An EU authorized representative is a legal entity based in the European Union that acts on behalf of non-EU manufacturers to ensure their medical devices comply with EU regulations. It is mandatory for all non-EU manufacturers to appoint an authorised representative. The representative shares legal liability with the manufacturer for regulatory compliance.

Thus, the authorised representative is a legal person established in the EU who has received and accepted a written mandate from a manufacturer located outside the EU. They are governed by the EU MDR. The representative serves as the manufacturer’s official contact point with EU authorities and ensures compliance with EU medical device law.

7 Key responsibilities of an EU authorized representative

An EU authorized representative is legally responsible for ensuring that non-EU manufacturers’ medical devices comply with EU MDR. They share liability with the manufacturer and act as the official contact point for EU authorities.

1. Verification of compliance: Ensure the manufacturer has drawn up the EU declaration of conformity and technical documentation before placing devices on the market. Confirm that conformity assessment procedures have been carried out correctly. Check that devices bear the CE marking and meet MDR/IVDR requirements.
2. Documentation and record keeping: Maintain copies of technical documentation, EU Declaration of Conformity, Certificates issued by Notified Bodies. Keep these documents available for inspection by competent authorities.
3. Communication and representation: Act as the primary contact point for EU competent authorities and notified bodies. Cooperate with authorities during inspections, audits, or investigations. Forward requests for samples or information to the manufacturer and ensure timely responses.
4. Vigilance and post-market surveillance: Immediately inform the manufacturer of serious incidents and field safety corrective actions reported in the EU. Ensure the manufacturer complies with post-market surveillance obligations. Support reporting obligations to authorities when required.
5. Labeling and transparency: Ensure the EU authorized representative’s name, address, and contact details appear on device labelling, packaging, and Instructions for Use (IFU).This makes the representative visible to regulators, customers, and patients.
6. Liability and legal accountability: The authorised representative is jointly liable with the manufacturer for defective devices. It can face legal consequences (fines, sanctions, litigation) if devices are non-compliant and must have sufficient expertise in EU medical device laws to fulfill obligations.
7. Mandate agreement management: The relationship must be formalized in a written mandate signed by both parties. Agreement should clearly define scope of representation, responsibilities and liabilities, and termination conditions.

Step-by-step guide to selecting and managing an authorized representative

1. Determine the need: Confirm manufacturer is outside the EU/EEA and hence, needs a representative. Verify device falls under EU MDR.
2. Identify potential EU authorized representative: Assess regulatory expertise of the potential representative. Importantly, it must be a legal entity established in the EU. Furthermore, check their capacity to handle documentation, communication, and liability.
3. Evaluate competence: Review track record with notified bodies and competent authorities. Confirm ability to maintain technical documentation and Declaration of Conformity. Assess language capabilities for EU-wide communication.
4. Formalize mandate: Draft a written mandate agreement defining responsibilities. The mandate should include scope of representation, liability and indemnification clauses, vigilance reporting obligations, and termination conditions.
5. Register and notify: Ensure the EU authorized representative details are included in EUDAMED registration. Notify relevant competent authorities if required. Update device labeling and IFU with representative name and address.
6. Maintain documentation: The representative must hold technical files, CE certificates, post-market surveillance reports, and vigilance records. Ensure audit readiness at all times.
7. Monitor compliance: Conduct regular reviews of the representative performance. Verify vigilance reporting timelines are met. Ensure continuous updates for regulatory changes.
8. Audit and training: Include the representative in mock audits and CAPA programs. Provide training modules on product-specific risks. Educates the representative on manufacturer’s QMS procedures.
9. Commercial considerations: Evaluate cost structure (flat fee vs. per device) of the representative’s service. Ensure confidentiality agreements are in place. Consider multi-region representation if expanding globally.
10. Review and renewal: Periodically reassess the representative’s competence and responsiveness. Update mandate agreements as regulations evolve. Renew or change the representative if performance is unsatisfactory.

Liability and risks

Liabilities of EU authorized representative

• Shared legal responsibility: The authorised representative is jointly liable with the manufacturer for defective or non-compliant devices placed in the EU market.
• Civil and criminal liability: If a device causes harm due to non-compliance, both the manufacturer and authorized representative can face lawsuits, fines, or sanctions.
• Regulatory accountability: The authorized representative is accountable to EU competent authorities and must cooperate during inspections, audits, and investigations.
• Contractual liability: The written mandate agreement defines obligations, indemnification clauses, and termination conditions. If breached, the representative can face contractual disputes.

Risks for EU authorized representative

• Financial risk: Exposure to compensation claims, litigation costs, and penalties if devices are defective or unsafe.
• Reputational risk: Poor performance or association with non-compliant manufacturers can damage credibility with regulators and clients.
• Operational risk: The representative must maintain technical documentation, vigilance records, and surveillance data for the necessary period of time, which requires strong compliance systems.
• Regulatory risk: Continuous changes in MDR/IVDR guidance mean the authorised representative must stay updated or risk non-compliance.
• Conflict of interest risk: Acting for multiple manufacturers may create conflicts if obligations overlap or incidents occur simultaneously.

Why do you need an authorized representative for medical devices?

You need a European authorized representative, if you are a medical device or in vitro diagnostic (IVD) manufacturer located outside the European Union and want to market your products in the EU. Under the EU Medical Device Regulation and In Vitro Diagnostic Regulation, it is mandatory to appoint an authorized representative because they act as your official contact point with EU authorities. The authorized representative ensures that your devices meet regulatory requirements, verifies that technical documentation and declarations of conformity are in place, supports vigilance and post-market surveillance, and makes sure their details appear on product labeling. Notably, the authorized representative shares legal liability with the manufacturer for defective or non-compliant devices, which means regulators and customers can hold them accountable. Thus, without an authorized representative, non-EU manufacturers cannot legally place medical devices in the EU market.

Therefore, the EU authorized representative plays a pivotal role in bridging non-EU manufacturers with the European regulatory system. They ensure medical devices and IVDs meet the stringent requirements of the MDR and IVDR. Notably, the representative holds shared legal responsibility with the manufacturer while serving as the official contact point for EU authorities. By maintaining documentation, overseeing vigilance, and ensuring transparency through labeling, the representative strengthens the manufacturer’s position in the European market. For assistance with obtaining CE marking for launching your medical device in the EU, feel free to email at [email protected] or call/Whatsapp on 9996859227.