What is an EU Authorised Representative, and do I need one?

In short: An EU Authorised Representative is an EU-based entity that acts for a manufacturer established outside the EU — verifying documentation, liaising with authorities, and sharing liability. You need one only if you have no legal entity in the EU. Its name appears on your label and in EUDAMED.

What the role covers

An Authorised Representative acts as your legal point of contact inside the EU: verifying that your technical documentation, declaration of conformity, and EU registration are in order, cooperating with competent authorities and market surveillance requests, and — importantly — being legally liable for defective devices on the same basis as, and jointly and severally with, you as the manufacturer (MDR Article 11(5)). An importer's liability arises separately, under its own obligations, not as part of this joint-and-several chain. This isn't a passive administrative service; a reputable Authorised Representative will actually review your documentation before agreeing to represent you, because their own liability depends on it.

When you do, and don't, need one

If your company is legally established in the EU, you don't need a separate Authorised Representative — your own EU entity fulfils that function. If you're incorporated outside the EU (a common situation for US or UK-first startups planning a later EU launch) and have no EU legal presence, MDR requires you to appoint one — a single Authorised Representative — before placing a device on the EU market. The Authorised Representative's name and address appear on your device label and packaging, and they're registered against your manufacturer record in EUDAMED.

Choosing one is a strategic decision, not a formality

Because liability is shared, the contract terms matter: what documentation review the Authorised Representative actually performs, what happens if they choose to terminate the relationship, and how quickly you could transfer to another one if needed. Treat this the same way you'd treat any other appointment that controls your ability to sell in a market — worth comparing more than one option, not defaulting to whichever entity responds first.

Where next: MDR Annex VIII: How Device Classes Are Set · Do I need an in-country representative in Saudi Arabia?

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