When entering the European market, medical device manufacturers often view the EU Authorized Representative (EU Rep) as a box to check — a mandatory figure required under Article 31 of the Medical Device Regulation (MDR 2017/745). While it’s true that having an EU Rep is a legal obligation for non-EU manufacturers, reducing this role to mere compliance misses a critical strategic opportunity.

In reality, your EU Authorized Representative can be a powerful ally in your European journey — far beyond signing documents or listing a European address on your label.

The Legal Minimum vs. Strategic Partnership

At a minimum, the EU Rep:

• Acts as your legal contact point for EU authorities and Notified Bodies
• Keeps a registered copy of your EU Declaration of Conformity and technical documentation
• Facilitates communication in case of safety concerns or field safety corrective actions (FSCAs)

But if you choose wisely, your EU Rep can also:

• Advise on country-specific market nuances (e.g., registration in France, Germany, or Spain)
• Support post-market surveillance (PMS) by helping monitor vigilance reports and national databases
• Coordinate with distributors to ensure labeling and documentation align with local expectations
• Act as an early warning system for regulatory changes or enforcement trends across EU member states

A Bridge, Not Just a Name on Paper

Think of your EU Rep as your eyes and ears in Europe. When issues arise — whether it’s a query from a national competent authority or a sudden request for updated clinical data — the speed and quality of your response can protect your reputation, avoid delays, and even prevent product recalls.

A proactive EU Rep doesn’t wait for problems to escalate. They:

• Monitor EUDAMED updates and national registries
• Alert you to upcoming deadlines (e.g., UDI submissions, SRN registrations)
• Help maintain your technical documentation in a state of audit-readiness

This level of support becomes especially valuable for small and mid-sized manufacturers who lack a physical presence in Europe but still need to operate with the agility and compliance rigor of a local player.

Choosing the Right Partner Matters

Not all EU Representatives are created equal. Some offer only a “letterbox” service — a registered address with minimal engagement. Others, like MHP, integrate regulatory expertise with deep commercial insight, offering a holistic gateway to Europe.

Ask yourself:

• Does my EU Rep understand MDR inside and out?
• Can they explain what a “legacy device” strategy entails?
• Do they have experience working with Notified Bodies during audits?
• Can they connect me with trusted local partners if I’m ready to scale?

If the answer is “no” to any of these, you may be missing out on strategic value.

Final Thought

Your EU Authorized Representative isn’t just a regulatory formality — it’s your first line of defense and your closest ally in the European market. Choosing a partner who combines legal compliance with real-world expertise can mean the difference between simply being present in Europe… and truly succeeding there.

At MHP, we don’t just fulfill the role of EU Rep — we help you navigate, grow, and thrive in one of the world’s most demanding and rewarding medical markets.

Ready to turn your EU representation into a strategic advantage?
Contact us to learn how MHP supports medical device manufacturers with integrated regulatory and commercial solutions across Europe.