EU Authorised Representative
Understanding EU Authorised Representatives in Medical Device Regulation
Navigating the complexities of EU medical device regulations is crucial for manufacturers, particularly those outside the European Union. The EU Authorised Representative (EU AR) plays a pivotal role in ensuring compliance with the Medical Device Regulation (MDR, Regulation (EU) 2017/745) and the In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746).
For non-EU manufacturers, appointing an EU AR isn’t just a regulatory requirement—it’s a critical step toward achieving market access and building trust in the European healthcare sector.
Who Needs an EU Authorised Representative?
Non-EU manufacturers of medical devices and in vitro diagnostic devices must designate an EU AR to legally sell their products within the EU. This mandate applies to all device classifications:
MDR: Class I (low risk) to Class III (high risk).
IVDR: Class A to Class D devices.
Why Is an EU AR Necessary?
Without an EU AR, non-EU manufacturers cannot:
Affix the CE mark to their devices.
Conduct required conformity assessments.
Meet legal obligations for market entry.
What Is the Role of an EU Authorised Representative?
The EU AR serves as a vital liaison between manufacturers and EU regulatory authorities, ensuring adherence to MDR and IVDR requirements. Their responsibilities encompass the following areas:
1. Representation and Regulatory Liaison
Act as the legal representative for manufacturers within the EU.
Facilitate communication during audits, inspections, or adverse event investigations.
2. Document Review and Accessibility
Verify that essential documents, such as the Declaration of Conformity and Technical Documentation, are complete and accessible.
Provide these documents to EU Competent Authorities when required.
3. Post-Market Obligations
Support Post-Market Surveillance (PMS) and vigilance activities, including incident reporting.
Ensure compliance with periodic safety update reports (PSUR) and summary of safety and clinical performance (SSCP) requirements.
4. Device Registration
Oversee device registration in EUDAMED (the European Database on Medical Devices).
5. Labeling Compliance
Verify device labeling includes the EU AR’s name and address as mandated by MDR/IVDR.
What Documents and Agreements Are Required?
Establishing a compliant relationship with an EU AR involves comprehensive documentation and formal agreements.
1. Mandate Agreement
A written agreement defining:
Representation scope.
EU AR responsibilities in regulatory compliance.
Liability and termination clauses.
2. Declaration of Conformity
The EU AR must confirm the validity of the manufacturer’s Declaration of Conformity to EU standards.
3. Technical Documentation
Ensure access to the manufacturer’s:
General Safety and Performance Requirements (GSPR) checklist.
Risk management file (ISO 14971 compliance).
Clinical evaluation report (CER) or performance evaluation report (PER).
Instructions for Use (IFU) and labeling.
4. Post-Market Surveillance (PMS) Plan
Verify a robust PMS system, including:
Post-Market Clinical Follow-Up (PMCF) plans.
Vigilance reporting procedures.
5. EUDAMED Registration
Facilitate registration of devices and economic operators in the EUDAMED database.
6. Incident and Recall Management
Ensure protocols for managing incidents, recalls, and Field Safety Corrective Actions (FSCAs).
Why Is Choosing the Right EU AR Critical?
The EU AR shares responsibility for compliance and may face penalties for regulatory breaches. Manufacturers should prioritize representatives with:
Extensive regulatory expertise.
Robust quality management systems.
Effective communication skills.
Conclusion
An EU Authorised Representative is more than a regulatory formality; they are a strategic ally in navigating the intricacies of EU medical device regulations. By fostering clear agreements and ensuring comprehensive compliance, manufacturers can confidently introduce their devices to the European market.
Ready to ensure compliance and streamline your EU market entry? Contact us for assistance with mandate agreements or MDR/IVDR compliance verification!