EU Authorized Representative (EC REP): Complete Guide for Medical Device and IVD Manufacturers

Why Non-EU Manufacturers Need an EU Authorized Representative

If your medical device or IVD company is not established within the European Union, you cannot legally place devices on the EU market without appointing an EU Authorized Representative (EU AR, also called EC REP). This requirement has existed since the Medical Devices Directive era and continues — with expanded obligations — under the current Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).

Article 11 of both the MDR and IVDR explicitly states: manufacturers not established in the Union must designate a single authorized representative established in the Union. This is not optional — it is a mandatory prerequisite for EU market access.

Without an EU AR:

• Your devices cannot complete EUDAMED registration
• Notified Bodies will not issue CE certificates
• Your products may be stopped at the EU border
• You will face a non-conformance finding during Notified Body audits

This guide covers everything you need to know about the EU AR role, legal requirements, costs, selection criteria, and compliance obligations under the 2026 regulatory landscape.

What Is an EU Authorized Representative?

An EU Authorized Representative is a legal entity established within the European Union that acts as the regulatory interface for manufacturers not established in the EU. The EU AR represents the manufacturer for regulatory compliance matters related to placing medical devices and IVDs on the EU market.

Key facts:

• Can be an individual or a company, as long as they are established in an EU Member State
• Must have a physical address in the EU (letterbox companies are not sufficient)
• Must have a written mandate from the manufacturer
• Acts as the point of contact between the manufacturer and EU Competent Authorities
• Must have permanent access to a Person Responsible for Regulatory Compliance (PRRC)

The EU AR is identified on product labeling and packaging using the EC REP symbol (per ISO 15223-1). Note: a draft amendment to ISO 15223-1 proposes changing the symbol from "EC REP" to "EU REP," though the current symbol remains valid.

When Do You Need an EU AR?

You need an EU Authorized Representative if:

1. Your legal manufacturing address is outside the EU/EEA — This includes manufacturers based in the United States, Japan, China, UK (post-Brexit), Switzerland, or any other non-EU/EEA country
2. You place medical devices on the EU/EEA market under MDR 2017/745 or IVDs under IVDR 2017/746
3. All device classes are covered — Class I, IIa, IIb, III for medical devices; Class A, B, C, D for IVDs

You do not need an EU AR if your company has a registered legal entity within the EU.

Legal Framework: MDR/IVDR Article 11

EU AR Obligations (Article 11, Paragraph 3)

The mandate between the manufacturer and EU AR must require the AR to perform at minimum the following tasks:

Obligation	Description
(a) Verify documentation	Verify that the EU declaration of conformity and technical documentation have been drawn up, and where applicable, that an appropriate conformity assessment procedure has been carried out
(b) Maintain records	Keep copies available of technical documentation, EU declarations of conformity, and certificates (including amendments and supplements) and make them accessible to authorities on request
(c) Verify EUDAMED registration	Verify that the manufacturer has registered the requested information in EUDAMED
(d) Respond to authorities	Provide competent authorities with all information and documentation necessary to demonstrate conformity, upon reasoned request
(e) Forward requests	Immediately forward to the manufacturer any requests from competent authorities for samples or access to devices
(f) Cooperate with authorities	Cooperate with competent authorities on any preventive or corrective action taken to eliminate or mitigate risks posed by devices
(g) Report complaints	Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients, and users about suspected incidents
(h) Terminate if necessary	Terminate the mandate if the manufacturer acts contrary to its obligations under the Regulation

Tasks That Cannot Be Delegated (Article 11, Paragraph 4)

The mandate cannot delegate the manufacturer's exclusive responsibilities, including:

• Design of the device
• Quality management system
• Drafting of technical documentation
• Obligations under Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11), and (12)

These remain the sole responsibility of the manufacturer.

Liability (Article 11, Paragraph 5)

The EU AR can be held jointly and severally liable with the manufacturer for defective devices, but this liability is conditional — it only applies when the manufacturer has not complied with its obligations under the Regulations and is not established in the EU.

This means:

• The EU AR has strong incentive to verify manufacturer compliance
• The EU AR should terminate the mandate if the manufacturer acts contrary to its obligations
• Upon termination, the EU AR must immediately inform the competent authority and, where applicable, the Notified Body

The Mandate Agreement: What Must Be Included

The relationship between manufacturer and EU AR is formalized through a written mandate (sometimes called an agreement or contract). Together, these documents establish the legal relationship.

Minimum Mandate Requirements

The mandate must cover:

• Identity and contact details of both parties
• Scope of devices covered by the mandate (must cover at least all devices of the same generic device group)
• Specific tasks and obligations of the EU AR per Article 11(3)
• Duration and termination conditions
• Procedures for authority requests and communications
• EUDAMED registration responsibilities
• Fees and payment terms
• Confidentiality provisions
• Procedures for handling vigilance reports and field safety corrective actions

Changing Your EU AR

If you change your EU Authorized Representative, Article 12 MDR/IVDR requires a specific agreement between the manufacturer, the outgoing EU AR, and the incoming EU AR. This agreement must define:

• The exact date of transfer of responsibilities
• The date on which the outgoing EU AR's obligations end
• Any remaining obligations of the outgoing EU AR (e.g., handling legacy complaints)
• The handover of documentation and records

Important: The outgoing EU AR must continue to fulfill its obligations until the new EU AR is fully registered and functional. There must be no gap in representation.

PRRC Requirements for EU Authorized Representatives

Under Article 15(6) of the MDR and IVDR, the EU AR must have permanent and continuous access to a Person Responsible for Regulatory Compliance (PRRC).

Key requirements:

• The PRRC must possess the requisite expertise in the field of medical devices
• The EU AR's PRRC must be distinct from the manufacturer's PRRC (per MDCG 2022-16)
• The PRRC is responsible for ensuring compliance with post-market surveillance and vigilance obligations
• The PRRC must be an employee of the EU AR or available through a service contract

EUDAMED Registration Requirements

With EUDAMED becoming mandatory starting May 28, 2026, EU Authorized Representatives face new compliance obligations:

Deadline	Requirement
28 May 2026	All economic operators (including EU ARs) must complete Actor Registration and obtain an SRN
28 May 2026	New MDR/IVDR devices must be registered in EUDAMED before first placement on the market
27 November 2026	Legacy devices (MDD/AIMDD/IVDD) must be registered in EUDAMED
28 May 2027	Notified Bodies complete uploading certificates issued before May 2026

What EU ARs Must Do for EUDAMED

• Register as an economic operator in the Actor Registration module
• Obtain a Single Registration Number (SRN)
• Verify that the manufacturer has registered device information
• Ensure their data is linked to the manufacturers they represent
• Non-EU manufacturers need verification from their EU AR before competent authorities process registrations

EU AR vs. Other Representatives: Understanding the Differences

The EU AR is one of several representative roles across European and global markets. Understanding the differences is essential:

Role	Jurisdiction	Applicable To	Key Differences
EU AR (EC REP)	EU/EEA	Non-EU manufacturers under MDR/IVDR	Mandated by Article 11; joint liability; PRRC required
UK Responsible Person (UKRP)	United Kingdom	Non-UK manufacturers under UK MDR 2002	Separate appointment required post-Brexit; UKCA marking
Swiss Authorized Representative (CH-REP)	Switzerland	Non-Swiss manufacturers under Swiss TPMD	Swissdamed registration required; Switzerland is not in the EU
US Agent	United States	Non-US manufacturers registering with FDA	Primarily for establishment registration; less comprehensive role

UK manufacturers need an EU AR for EU market access. EU manufacturers need a UKRP for UK market access. Neither is reciprocal.

EU AR Costs: What to Expect

EU Authorized Representative fees vary by provider, device class, and scope of services. Based on current market data:

Representative Fee Structure

MDR Device Class	Annual AR Fee	EUDAMED Setup Fee	Actor + SRN Activation	Total First Year
Class I	€900 - €2,000	€300	€400	€1,600 - €2,700
Class Is/Im/Ir	€1,000 - €2,500	€300	€400	€1,700 - €3,200
Class IIa	€1,100 - €3,000	€300	€400	€1,800 - €3,700
Class IIb	€1,200 - €3,500	€300	€400	€1,900 - €4,200
Class III	€1,300 - €4,000+	€300	€400	€2,000 - €4,700+

IVDR Device Class	Annual AR Fee	EUDAMED Setup Fee	Actor + SRN Activation	Total First Year
Class A	€900	€300	€400	€1,600
Class B	€1,100	€300	€400	€1,800
Class C	€1,200	€300	€400	€1,900
Class D	€1,300	€300	€400	€2,000

Source: Pricing data from EU AR service providers effective January 2026

Additional Common Fees

Service	Typical Fee
Additional device registration	€100 per device
Mandate/agreement modification	€150
No Objection Certificate (NOC)	€100
Declaration of Conformity drafting (Class I)	€400
Free Sale Certificate application	€2,000
EU Registration with competent authority	€600 per device

Some providers (e.g., Casus Consulting) charge flat annual fees that include technical documentation review for higher-risk devices, while charging document review fees separately for Class I devices and self-certified IVDs. Others (e.g., Pure Global) offer flat annual fees starting at $2,000/year with EUDAMED support included.

How to Select an EU Authorized Representative

Choosing the right EU AR is a critical business decision. Consider these factors:

1. Regulatory Expertise

• Does the EU AR have experience with your device type and risk class?
• Can they provide PRRC-level regulatory support?
• Do they understand the specific MDR/IVDR requirements applicable to your devices?

2. Responsiveness and Communication

• Will you have a dedicated contact person or a generic inbox?
• What are their response time commitments for authority inquiries?
• Can they handle urgent vigilance communications within required timelines?

3. Scope of Services

• Does the fee include technical documentation review?
• Is EUDAMED registration support included?
• Do they handle vigilance reporting and field safety corrective action coordination?
• Can they support multiple device classes and types?

4. Geographic Coverage

• Which EU Member State are they established in? This determines which competent authority has primary oversight
• Do they have the capacity to handle multi-country market surveillance requests?

5. Fee Transparency

• Are fees all-inclusive or will you face additional charges for document reviews, EUDAMED activities, or authority communications?
• What triggers additional fees?
• Are annual increases capped?

6. Independence and Conflict of Interest

• The EU AR should be independent from your distributor to avoid conflicts of interest
• While an importer can legally serve as EU AR, this creates potential role conflicts
• Subsidiaries can only serve as EU AR if they have legal independence and their own PRRC

Red Flags to Avoid

• Providers that offer unrealistically low fees without explaining what is excluded
• EU ARs that cannot demonstrate PRRC access
• Companies that serve as both your distributor and EU AR (conflict of interest)
• Providers without a physical presence in the EU (letterbox companies are insufficient)
• EU ARs that are unwilling to share their standard mandate agreement for review before signing

Timeline for Appointing an EU AR

The EU AR appointment should be one of the first steps in your EU market access strategy:

Phase	Action	Timeline
Planning	Identify and evaluate EU AR providers	2-4 weeks
Due diligence	Review mandate agreement, negotiate terms	2-4 weeks
Appointment	Sign mandate agreement	1-2 weeks
EUDAMED setup	Register EU AR in Actor module, obtain SRN	4-6 weeks (depends on authority processing)
Documentation	EU AR reviews technical documentation	2-8 weeks (depends on device complexity)
Notified Body	EU AR information included in conformity assessment	Concurrent with NB application
Ongoing	Annual compliance review, EUDAMED updates, vigilance support	Continuous

Key Takeaways

1. EU AR appointment is mandatory for all non-EU medical device and IVD manufacturers — no exceptions
2. Article 11 MDR/IVDR defines the EU AR's minimum obligations, which cannot be delegated away from the manufacturer's exclusive responsibilities
3. Joint liability means your EU AR has strong incentive to verify your compliance — choose a partner, not just a service provider
4. EUDAMED is now mandatory — your EU AR must be registered with an SRN by May 28, 2026
5. Budget €1,600-€4,700+ for the first year, depending on device class and provider
6. Plan for a 4-8 week onboarding process before your EU AR is fully operational
7. Avoid conflicts of interest — don't appoint your distributor as your EU AR