If you're a medical device manufacturer based outside the European Union, there's one critical role you need to understand before entering the EU market: the Authorized Representative (AR). This isn't just a regulatory checkbox—it's your mandatory legal presence in Europe, and choosing the right AR can make or break your market access strategy.
What Is an Authorized Representative?
An Authorized Representative is a natural or legal person established within the EU who acts on behalf of a non-EU manufacturer. Think of them as your legal representative, compliance partner, and communication bridge with EU authorities—all rolled into one.
Under both the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746), having an AR isn't optional for non-EU manufacturers—it's a legal requirement.
The Legal Mandate: Why You Can't Skip This
Article 11 of the EU MDR and IVDR is crystal clear: any manufacturer established outside the EU must designate an AR by written mandate. Without an AR, you simply cannot:
- Place devices on the EU market
- Register your devices in EUDAMED (the EU medical device database)
- Maintain legal compliance with EU regulations
- Respond to competent authority inquiries
Your AR becomes your legal address in the EU. All communication from regulatory authorities, post-market surveillance activities, and compliance verification will go through them.
Core Responsibilities: What Your AR Actually Does
Your Authorized Representative isn't just a mailbox service. They have substantial legal responsibilities:
Regulatory Communication
- Serve as the point of contact for competent authorities
- Receive and respond to requests for information, documentation, and samples
- Handle inquiries about device safety and performance
Compliance Verification
- Verify that the EU Declaration of Conformity and technical documentation exist
- Confirm that manufacturers have fulfilled their conformity assessment obligations
- Ensure proper CE marking and registration procedures are followed
Post-Market Surveillance
- Maintain and make available documentation related to post-market surveillance
- Cooperate with authorities on corrective actions and field safety notices
- Keep manufacturers informed of regulatory developments and requirements
Device Registration
- Register devices in EUDAMED on behalf of the manufacturer
- Maintain accurate device information in the database
- Update registration as products or regulatory status changes
Beyond Compliance: The Strategic Value of a Good AR
While the legal requirements are clear, a skilled AR brings value beyond basic compliance:
Market Intelligence: Your AR can provide insights into EU regulatory trends, upcoming changes, and enforcement patterns that might affect your business.
Faster Response Times: With someone in the EU time zone handling communications, you avoid delays in responding to authority requests.
Cultural and Language Bridge: Regulatory communication isn't just about translation—it's about understanding local regulatory culture and expectations.
Risk Mitigation: An experienced AR can spot potential compliance issues before they become problems with authorities.
Choosing the Right AR: Critical Selection Criteria
Not all Authorized Representatives are created equal. Consider these factors:
Regulatory Expertise: Do they understand your specific device category and risk class? Have they worked with similar products?
Resources and Infrastructure: Can they handle your volume of communications and documentation requirements? Do they have proper quality systems?
Geographic Coverage: Are they positioned to effectively communicate with competent authorities across all EU member states where you plan to sell?
Track Record: Ask for references from other non-EU manufacturers. What's their response time? How do they handle crises?
Cost Structure: Understand not just the fees, but what's included and what's additional. Cheap can become very expensive if they're not responsive or competent.
Common Misconceptions
"My distributor can be my AR": Not necessarily. While distributors can serve as ARs if they meet the requirements, the roles are distinct. Your distributor's commercial interests might not always align with regulatory responsibilities.
"Any EU-based company can be my AR": Technically yes, but they need regulatory expertise and proper infrastructure. An unprepared AR is worse than helpful.
"Once appointed, I can forget about EU regulations": Wrong. The AR represents you, but ultimate responsibility for compliance remains with the manufacturer.
The Bottom Line
For non-EU medical device manufacturers, an Authorized Representative isn't administrative overhead—it's your essential partner for European market access. The EU MDR and IVDR have made clear that regulators expect ARs to be competent, resourceful, and responsive.
Investing time in selecting the right AR pays dividends in smoother market access, faster problem resolution, and better regulatory relationships. In a market as complex and valuable as the EU, your AR choice is a strategic business decision, not just a compliance requirement.