MDR Compliance Guide

EU Authorized Representative Under MDR:
Who Needs One & How to Find the Right Partner

If you manufacture medical devices outside the EU and want to sell in the EU market, appointing an EU Authorised Representative is a legal requirement — not an option. This guide explains exactly what you need, why it matters, and what to look for when choosing your AR.

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What Is an EU Authorised Representative Under MDR?

An EU Authorised Representative (AR) is a natural or legal person established in the European Union who is explicitly designated by a non-EU manufacturer to act on their behalf in relation to specified tasks under the EU Medical Device Regulation (MDR 2017/745).

The legal basis is MDR Article 11. Any manufacturer without a registered place of business in the EU must, before placing a device on the EU market, designate an authorised representative. This representative becomes your legal point of contact for EU regulatory authorities, Notified Bodies, and market surveillance.

⚠ UK manufacturers are also affected Since Brexit, manufacturers established only in the United Kingdom are treated as non-EU manufacturers and must appoint an EU Authorised Representative to access the EU market.

Who Is Required to Appoint an EU AR?

You must appoint an EU AR if your company is a medical device manufacturer established outside the EU or EEA, and you want to place CE-marked devices on the EU market. This applies to manufacturers in:

United States, Canada, Mexico
United Kingdom (post-Brexit)
Turkey, Israel, Switzerland (when not covered by MRA), Serbia, Ukraine
China, Japan, South Korea, India, Taiwan
All other countries outside the EU/EEA

What Does an EU Authorised Representative Do?

EUDAMED Registration

Registers in EUDAMED and is linked to each device they represent. Checked during market surveillance.

Declaration of Conformity

Named in the DoC alongside the manufacturer. Details must appear on the device label or packaging.

Regulatory Authority Contact

Primary EU legal contact for national competent authorities (BfArM, ANSM, SÚKL, etc.) for questions, investigations, and inspections.

Incident Reporting

Cooperates on vigilance — serious incidents, field safety corrective actions (FSCAs), and periodic safety update reports (PSURs).

Technical Documentation

Must have access to technical documentation and DoC, and provide them to authorities within legally required timeframes.

Market Surveillance

Cooperates on recalls, safety alerts, and market withdrawals. Ensures the manufacturer acts in accordance with EU requirements.

💡 Key point on liability Under MDR Article 11(5), if a manufacturer fails to fulfil their obligations, the EU Authorised Representative can be held liable to the same extent as the manufacturer. This is why choosing a competent, experienced AR matters significantly.

What Information Must Appear on the Label?

Under MDR Annex I, the label or accompanying documentation must include the name and address of the EU Authorised Representative with the prescribed AR symbol. Failing to include correct AR information is a frequent market surveillance finding.

How to Choose the Right EU Authorised Representative

1. Experience with your device category

An AR for Class I general medical devices is very different from one representing Class III implantables. Your AR should understand the regulatory pathway for your specific product type and risk class.

2. EUDAMED readiness

As EUDAMED becomes fully mandatory, your AR must be actively registered and capable of submitting and maintaining your device registrations. Ask about their EUDAMED infrastructure.

3. Capacity and responsiveness

During a serious incident or market surveillance inspection, your AR must be reachable and able to act quickly. Ask about their incident response process and average response times.

4. Contract terms and exit conditions

Review the mandate agreement carefully — notice period for termination, liability caps, data access commitments, and what happens if the AR ceases operations.

✓ What a good mandate agreement includes Clear scope of devices covered · Defined responsibilities for vigilance reporting · Technical documentation access protocol · EUDAMED registration commitment · Termination notice period (30–90 days) · Liability allocation · Confidentiality provisions

Common Mistakes Non-EU Manufacturers Make

Appointing an AR too late — the AR must be in place before the device is placed on the EU market
Choosing the cheapest option without due diligence — an AR that goes out of business leaves you exposed
Not including the AR on the label — frequent market surveillance finding, can result in corrective action
Confusing the AR with a distributor or importer — these are distinct roles with distinct legal obligations
Failing to update EUDAMED when devices change — design changes require coordinated EUDAMED updates with your AR

EU AR vs CH-REP vs UKRP

EU AR

Required under MDR for all 27 EU member states + EEA (Norway, Iceland, Liechtenstein).

CH-REP

Swiss Authorised Representative, required under MedDO for the Swiss market. Separate from EU AR.

UKRP

UK Responsible Person, required under UK MDR 2002 for Great Britain market. Separate from EU AR.

Frequently Asked Questions

Who is required to appoint an EU Authorized Representative under MDR?

Any manufacturer established outside the EU who places a medical device on the EU market must appoint an EU AR under MDR Article 11. This includes manufacturers in the USA, Turkey, Israel, UK, China, India, Japan, and all other non-EU countries.

Can one Authorized Representative cover multiple products?

Yes. A single EU AR can cover multiple products and product families. Each device must be explicitly listed in the mandate agreement and registered in EUDAMED.

What is the difference between an EU AR and an EU Importer?

An EU AR is a regulatory role — legal contact point for authorities, mandatory for non-EU manufacturers. An EU Importer is a commercial role — places products from non-EU manufacturers on the EU market. Both roles can be held by the same company or different ones.

How long does it take to appoint an EU AR?

Signing a mandate agreement typically takes 1–3 weeks. EUDAMED registration takes additional time. Plan for 4–8 weeks before placing devices on the EU market.

What happens if I sell medical devices in the EU without an AR?

Serious non-compliance. Can result in market withdrawal, prohibition of sale, and fines. EU customs and market surveillance bodies actively check AR registration.

Ready to Start?

Non-EU medical device manufacturers must appoint an EU Authorised Representative under MDR (Article 11).