EU Authorized Representative (EU AR)
Trusted by 250+ medical device & IVD manufacturers across 20 countries
✓ Complete EU AR representation from initial mandate through ongoing compliance
✓ Fast, responsive support from experienced regulatory professionals
✓ Direct access to your dedicated regulatory contact (no generic inboxes)
✓ Transparent, flat-fee pricing with no hidden costs
New to EU AR requirements? Learn more below ↓
Why You Need an EU Authorized Rep
Medical device and IVD manufacturers without a registered office in the European Union must appoint an EU Authorized Representative (EU AR) to place devices on the EU market. This has been a longstanding requirement since the Medical Devices Directive era and continues under the current Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).
The EU AR serves as your regulatory representative within the European Single Market, managing compliance obligations, maintaining technical documentation, and acting as your point of contact with EU Competent Authorities.
Note: Following Brexit, the UK now requires a separate UK Responsible Person (UKRP). Switzerland also requires a Swiss Authorized Representative (CH-REP). Compare EU AR vs UKRP vs CH-REP requirements
What Your EU Authorized Rep Does
As your EU AR, Casus handles all regulatory responsibilities required under MDR/IVDR:
Pre-Market Activities
- Execute the EU AR service agreement with clear obligations for both parties
- Verify technical documentation and conformity assessment procedures
- Maintain copies of technical files and CE marking certificates
- Authorize inclusion of EU AR information on device labeling and documentation
EUDAMED and Registration Support
- Assist with EUDAMED Single Registration Number (SRN) applications at no additional charge
- Verify manufacturer compliance with EUDAMED registration obligations
Ongoing Compliance, Post-Market, and Vigilance Activities
- Maintain technical documentation (10 years for non-implantables, 15 years for implantables)
- Serve as point of contact with EU Competent Authorities
- Provide technical files and declarations of conformity upon Competent Authority request
- Coordinate Certificate of Free Sale (CFS) requests for global market access
- Monitor and communicate EU regulatory updates affecting your compliance
- Forward complaints from healthcare professionals, patients, and users
- Support incident reporting and Field Safety Corrective Action (FSCA) coordination, as necessary
- Collaborate on preventive and corrective actions with authorities
Questions?
Explore how we can assist with your market entry. We would be happy to schedule a no-obligation call to discuss your needs.
Our EU AR Service Process
Timeline varies based on your current regulatory status.
For manufacturers with CE marking:
- Service Agreement (1-3 days): Sign your EU AR agreement and provide device technical documents. Our fast onboarding gets you started in days, not weeks.
- Documentation Review (3-5 days): Casus reviews your technical documentation for completeness. Note that Class I devices and Class A IVDs may take 2-3 weeks if manufacturers need to complete or update technical documentation to meet compliance requirements.
- EUDAMED Support (as needed): Assist with SRN application and registration verification.
- Ongoing Support: Direct access to your dedicated regulatory team for questions and help as needed.
For manufacturers seeking CE marking:
Timeline depends on device class, Notified Body involvement, and documentation completeness. We can serve as your EU AR during the Notified Body assessment process (required for technical file completion and NB audits) and provide ongoing representation through CE marking and beyond.
Straightforward EU AR Pricing
Many EU AR providers use complex fee structures that increase unexpectedly over time. Our approach is transparent and predictable.
Our Annual Fee Pricing Model:
- Flat annual fee: One price, no penalty or mid-contract fee increase to add products
- No year-two increases: Consistent pricing you can budget for
- General regulatory guidance included: Questions about EU requirements, labeling questions, and other general compliance covered at no additional charge
- No monthly billing cycles: Simple annual payment, no recurring processing
Our Device Document Review Fees:
The MDR/IVDR requires EU Authorized Representatives to verify technical documentation and conformity assessment procedures.
We charge for technical documentation review only for low-risk devices (Class I medical devices and Class A/self-certified IVDs), where independent Notified Body review has not occurred or was limited in scope. For higher-risk devices (Class IIa-III, Class B-D IVDs), documentation review is included in the annual fee; we don’t duplicate work your Notified Body has already performed.
What other providers charge extra for:
- Adding devices mid-contract (we don’t)
- Monthly “support hours” packages (our guidance is included)
- Annual fee escalations based on portfolio size (ours stay flat)
- Documentation review for all device classes regardless of NB involvement (we only charge where necessary)
EU AR, UKRP, and CH-REP: Understanding the Differences
If you’re entering multiple European markets, understanding the individual requirements for each region is important.
| Requirement | EU AR (European Union) | UKRP (Great Britain) | CH-REP (Switzerland) |
|---|---|---|---|
| Regulation | MDR 2017/745, IVDR 2017/746 | UK MDR 2002 (as amended) | MedDO 812.213, IvDO 812.219 |
| Geographic Coverage | 27 EU member states, EEA (Iceland, Liechtenstein, Norway), and Northern Ireland (due to Windsor Framework) | Great Britain (England, Scotland, Wales) | Switzerland |
| When Required | Since Medical Devices Directive era (1990s) | Mandatory since January 2022 (Brexit) | Mandatory since May 2021 (medical devices) and May 2022 (IVDs) |
| Marking Required | CE marking | UKCA marking or CE marking | Swiss conformity marking or CE marking |
| Registration Database | EUDAMED | DORS | swissdamed |
| Labeling Requirement | EC REP symbol with name & address | UK Responsible Person in text with name & address (UKCA marked devices only) | CH REP symbol with name & address |
| Liability | Jointly liable with manufacturer for defective devices if manufacturer defaults on obligations | Currently limited liability (proposed changes 2026 to 2027) | Jointly liable with manufacturer for defective devices if manufacturer defaults on obligations |
Summary: While the roles are similar across regions, they are legally distinct. A single provider can serve all three roles if they maintain registered offices in the EU, UK, and Switzerland. Casus supports manufacturers across all three markets, streamlining your multi-region compliance.
EU AR Requirements & FAQs
Who needs an EU Authorized Representative?
Medical device and IVD manufacturers without a registered office in the European Union must appoint an EU AR before placing devices on the EU market. This has been a longstanding requirement since the Medical Devices Directive (MDD) era and continues under the current MDR and IVDR regulations.
What happens if I don’t appoint an EU AR?
Non-EU manufacturers cannot legally place medical devices on the EU market without an appointed EU AR. Marketing devices without proper EU AR representation violates MDR/IVDR requirements and subjects your devices to enforcement action by EU authorities. Additionally, manufacturers cannot complete EUDAMED registration without an appointed EU AR, and operating without an EU AR would result in a non-conformance finding during Notified Body audits.
How long does it take to appoint an EU Authorized Representative?
For manufacturers with existing CE marking, the process from start to finish typically takes 2-4 weeks. For those still pursuing CE marking, the timeline depends on device class, Notified Body involvement, and documentation completeness.
Does the EU AR need to be on device labeling?
Yes. Under MDR and IVDR, the EU AR’s name and address must appear on the device label. The EC REP symbol (per EN ISO 15223-1) can be used to help reduce translation requirements. If label space is limited, the information can appear on unit packaging or outer packaging. It’s not required on Instructions for Use (IFU), though including it there may improve traceability.
For legacy devices marketed under older Directives (MDD, AIMDD, IVDD), EU AR information can appear on the label, outer packaging, or IFU.
Can my distributor be my EU Authorized Representative?
Legally, yes, a distributor can serve as your EU AR. However, this creates several practical challenges.
Conflict of interest: If regulatory issues arise (supply chain problems, customer complaints, authority inspections), your distributor may prioritize protecting their own business interests rather than representing you effectively.
Competitive complications: Since the EU AR’s name and address must appear on device labeling, having a distributor serve as your EU AR means their contact information is visible to all other distributors and potential competitors in the market. This can create commercial tensions and may limit your ability to work with other distribution partners.
Regulatory risk: If your distributor-EU AR fails to meet their regulatory obligations or faces compliance issues with authorities, it puts your entire EU market access at risk.
Many manufacturers prefer an independent EU AR to avoid these conflicts and maintain flexibility in their European distribution strategy.
Does my EU AR need to be in a specific EU country?
No, your EU AR can be established in any EU member state or European Economic Area (EEA) country (such as Norway, Iceland, or Liechtenstein). The AR’s registered address will appear on your device labeling and in regulatory documentation.
Can one EU AR represent all my devices?
Yes, and in fact, a single EU AR must represent all devices within the same generic device group (product family) under one service agreement. However, if you have devices in multiple distinct generic device groups, you can appoint different EU ARs for each group if there’s a business reason to do so. For example, an exclusive distributor for one product line might serve as EU AR for that family, while you maintain an independent EU AR for other product families to preserve flexibility and avoid conflicts of interest.
What documentation does the EU AR need from me?
Your EU AR needs technical files, declarations of conformity, CE marking certificates (if applicable), labeling specimens, and instructions for use. We provide a detailed document checklist during onboarding to ensure a smooth setup process.
How do I transfer my EU AR to Casus?
The transfer process typically takes 2-4 weeks and involves:
- Executing a new EU AR service agreement with Casus
- Coordinating end date with your previous EU AR and start date with Casus
- Updating labeling to reflect new EU AR information (can be phased as existing inventory depletes)
- Transferring technical documentation and compliance records
- Updating EUDAMED registrations as needed
Per MDR/IVDR Article 12, a transfer agreement signed by all three parties (manufacturer, outgoing EU AR, incoming EU AR) should define these arrangements and ensure your previous EU AR forwards any complaints received for devices placed on market before the transfer date. Learn more about the EU AR transfer process
What’s the difference between an EU AR mandate and agreement?
These terms are often used interchangeably. The “mandate” is a term used in the MDR/IVDR and refers to the written authorization granted by the manufacturer to the EU AR to act on its behalf. The “agreement” or “contract” is the formal document outlining responsibilities, duties, and obligations of both parties. Together, they establish the legal relationship between manufacturer and EU AR.
Am I still liable for my devices even though I have an EU AR?
Under Article 11(5) of the MDR/IVDR, the EU AR can be held jointly and severally liable with the manufacturer for defective devices, but this liability is conditional and only applies when:
- The manufacturer’s liability for a defective device is first established under applicable EU or national product liability law, and
- It is proven that the manufacturer has failed to comply with their obligations under Article 10 of the MDR/IVDR
In other words, the EU AR’s liability is triggered only if the manufacturer defaults on their regulatory obligations. Per MDCG 2022-16 guidance, this means the EU AR has a strong interest in verifying that manufacturers maintain appropriate product liability insurance and fulfill all MDR/IVDR obligations.
This conditional liability structure underscores the importance of selecting a diligent, experienced EU AR who actively monitors manufacturer compliance and maintains proper documentation.
Do I Need ISO 13485 to Sell in Europe?
No, ISO 13485 certification is not required for CE marking or EU market access.
However, you must demonstrate that your quality management system meets MDR/IVDR requirements. How this is verified depends on your device class:
Higher-risk devices: A Notified Body will assess your QMS as part of the CE marking process
Low-risk devices (Class I non-sterile/non-measuring/non-reusable medical devices and Class A non-sterile IVDs): You’re responsible for ensuring your QMS meets requirements; no third-party verification required
Ready to Enter the EU Market?
Get your custom quote and timeline for EU Authorized Representative services. Our team will assess your specific requirements and provide transparent pricing.
Questions about EU AR requirements? Contact our team.
