If your manufacturing entity is located outside the European Union, you cannot place medical devices on the EU market without an authorized representative. This is not optional. Article 11 of the MDR requires non-EU manufacturers to designate an authorized representative established within the Union before placing any device on the market .

For EU-based startups, this article may not apply directly. But if you are a non-EU startup targeting the European market, or if your manufacturing entity is incorporated outside the EU, the authorized representative requirement is one of your first regulatory decisions.

What Is an Authorized Representative?

Article 2(32) defines an authorized representative as any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the manufacturer's obligations under the MDR .

The authorized representative acts as the manufacturer's legal presence in the EU. They are the point of contact for competent authorities and Notified Bodies, and they share legal responsibility for certain manufacturer obligations.

When Do You Need an Authorized Representative?

The rule is clear: if the manufacturer is not established in a member state, the device may only be placed on the Union market if the manufacturer designates an authorized representative (Article 11(1)) .

"Established in a member state" means having a registered legal entity in an EU member state (or EEA country — Iceland, Liechtenstein, Norway) .

Scenarios where you need an authorized representative: - Your startup is incorporated in the US, UK, Switzerland, Israel, or any non-EU/EEA country - Your manufacturing subsidiary is outside the EU even though your sales entity is in the EU (it is the manufacturer entity's location that matters) - You are a UK company post-Brexit targeting the EU market

Scenarios where you do not need one: - Your startup is incorporated in an EU or EEA member state — you are established in the Union - You have a subsidiary incorporated in an EU member state that serves as the manufacturer

What Are the Authorized Representative's Obligations?

Article 11(3) defines the tasks that the authorized representative must perform under the written mandate :

Verify requirements. The authorized representative must verify that the EU Declaration of Conformity and the technical documentation have been drawn up, and that the manufacturer has carried out the applicable conformity assessment procedure.

Keep documentation available. The authorized representative must keep the EU Declaration of Conformity, the technical documentation, and any applicable certificates available for competent authorities for the required retention period (typically 10 years after the last device was placed on the market).

Cooperate with competent authorities. The authorized representative must respond to requests from competent authorities and provide them with all the information and documentation necessary to demonstrate the device's conformity.

Forward complaints and reports. The authorized representative must forward to the manufacturer any request by a competent authority for samples or access to the device.

Terminate the mandate if the manufacturer acts non-compliantly. If the manufacturer does not fulfill its obligations under the MDR, the authorized representative must terminate the mandate and inform the competent authority and, where applicable, the Notified Body .

Liability. Article 11(5) states that the authorized representative is jointly and severally liable with the manufacturer for defective devices, in relation to any damage caused .

How Do You Choose an Authorized Representative?

Qualifications and Competence

The authorized representative must have the organizational and operational capacity to fulfill the tasks specified in the mandate. Article 11(2) states that the mandate must allow the authorized representative to have permanently available at least one person with expert knowledge of EU medical device regulatory requirements .

In practice, this means you should select an authorized representative that: - Has experience with medical devices in your device category - Understands the MDR and its practical implementation - Has established relationships with competent authorities - Has systems in place for document management, complaint handling, and regulatory communication

Scope of Services

Some authorized representatives provide only the minimum mandate services — document storage, competent authority communication, and registration. Others offer additional services: - Regulatory consulting - Notified Body communication support - Vigilance reporting assistance - UDI and EUDAMED registration support - Import and logistics coordination

Define what you need beyond the mandatory minimum. For a startup with limited EU presence, an authorized representative that provides broader regulatory support can be valuable.

Liability and Insurance

Because the authorized representative shares liability, they must have adequate insurance. Ask about their professional liability coverage and verify it covers the scope of your mandate.

Cost

Authorized representative fees typically include: - An annual retainer for the mandate and basic services - Per-device or per-certificate fees for registration and document management - Additional fees for services beyond the basic mandate

Costs vary widely — from a few thousand euros per year for a simple mandate to significantly more for comprehensive service packages. Get quotations from multiple providers.

Contract Structure

The mandate is a written agreement between the manufacturer and the authorized representative. It must specify the tasks the authorized representative is mandated to perform and must be signed by both parties.

Key contract considerations: - Scope of mandate: Define exactly which devices and which tasks are covered - Duration and termination: How long does the mandate last? Under what conditions can either party terminate? - Liability allocation: How is liability shared between manufacturer and authorized representative? - Communication obligations: What information must the manufacturer provide, and how quickly? - Fees and payment terms: Clear fee structure and payment schedule

What About UK Companies Post-Brexit?

Since the UK left the EU, UK-based manufacturers are non-EU manufacturers under the MDR. They must designate an authorized representative in an EU member state to sell devices on the EU market.

This is separate from any UK regulatory requirements. To sell in both the EU and the UK, a UK manufacturer needs MDR compliance with an EU authorized representative for the EU market, and UK MDR (as implemented) compliance for the UK market. See MDR and Brexit: Selling Medical Devices in the UK as an EU Startup.

Common Mistakes with Authorized Representatives

Choosing based solely on cost. The cheapest authorized representative may not have the competence or capacity to actually fulfill the mandate obligations. If they cannot respond to a competent authority request promptly, the manufacturer faces enforcement consequences.

Treating the mandate as a formality. The authorized representative has real legal obligations and real liability. The relationship requires active management — keeping documents current, communicating changes, ensuring the authorized representative has what they need to function.

Not updating the mandate when things change. If you add new devices, change your classification, or modify your intended purpose, the mandate may need to be updated. A mandate that does not cover your current product portfolio is a compliance gap.

Confusing authorized representative with regulatory consultant. An authorized representative fulfills specific legal obligations under Article 11. A regulatory consultant provides advisory services. Some organizations offer both, but they are different functions with different legal implications.

For EU-Based Startups: When Does This Apply to You?

If your startup is established in the EU, you do not need an authorized representative. However, you may need to understand the authorized representative framework if: - You acquire or partner with a non-EU manufacturer - You expand manufacturing outside the EU - Your corporate restructuring moves the manufacturer entity outside the EU - You import devices from non-EU manufacturers as part of your product portfolio

Understanding the authorized representative framework also helps you evaluate potential partners and suppliers who may be non-EU manufacturers selling into the EU market.

Next: MDR Obligations for Importers and Distributors: A Guide for Startup Sales Channels.