EU Authorised Representative Services for Medical Devices (EU MDR Compliance)
Our EU Authorised Representative (EU AR) services support non-EU medical device manufacturers in complying with EU MDR requirements and accessing the European market. Patient Guard Europe UG acts as your legally designated representative within the EU, ensuring full regulatory compliance and market readiness.
EU Authorised Representative Services
Under the EU Medical Device Regulation (EU MDR 2017/745), manufacturers based outside the European Union must appoint an EU Authorised Representative to place medical devices on the EU market.
The EU Authorised Representative acts as the official point of contact between the manufacturer and EU Competent Authorities, ensuring regulatory compliance and supporting post-market obligations.
Failure to appoint a compliant EU AR prevents market access and may result in regulatory enforcement actions.
Patient Guard Europe UG provides professional EU Authorised Representative services tailored to medical device and IVD manufacturers. We ensure your documentation, labelling, and regulatory obligations meet EU MDR requirements.
Our team supports you throughout the entire lifecycle—from initial compliance to post-market surveillance—ensuring your devices remain compliant within the EU.
Why Choose Patient Guard as Your EU Authorised Representative?
Established regulatory consultancy since 2017
We specialise in EU MDR compliance and medical device regulatory support.
Trusted by 500+ companies
We support manufacturers globally across a wide range of medical device classifications.
EU-based legal entity
Patient Guard Europe UG is based in Germany, fulfilling EU MDR requirements for Authorised Representatives.
Transparent pricing
Clear annual pricing with no hidden fees.
MDR expertise
We ensure your documentation, labelling, and processes align with EU MDR expectations.
Ongoing regulatory support
We provide continuous compliance support beyond initial market entry.
As your EU AR, we take on joint legal liability for your devices. Unlike ‘mailbox’ representatives, we perform a robust initial due diligence audit of your Technical File to ensure your certification remains stable and your liability is covered by our comprehensive professional indemnity insurance
Our Article 11 Mandate Obligations
Legal representation within the EU
We act as your official EU Authorised Representative in accordance with Article 11 of EU MDR.
Verification of technical documentation
We review your technical documentation to ensure compliance with EU MDR requirements.
Declaration of Conformity review
We verify that your EU Declaration of Conformity is complete and compliant.
Registration support (EUDAMED)
We support manufacturer and device registration within EUDAMED.
Labelling and IFU review
We ensure correct EU AR details are included on labelling and Instructions for Use.
Competent Authority liaison
We act as your point of contact with EU Competent Authorities.
Vigilance and incident support
We support reporting of serious incidents and field safety corrective actions.
Post-market surveillance support
We assist in maintaining ongoing compliance and regulatory obligations.
Operating through our German entity, Patient Guard Europe UG, ensures your products are registered with BfArM. German registration is recognized for its high standards, providing your brand with an additional layer of regulatory prestige and stability within the Union
Who Requires an EU Authorised Representative?
- Non-EU medical device manufacturers
- Companies placing devices on the EU market
- Organisations seeking CE marking under EU MDR
- Distributors requiring compliant EU representation
EU MDR Authorised Representative Requirements
EU MDR (Article 11) requires:
- A written mandate between manufacturer and EU AR
- Verification of technical documentation
- Availability of documentation for Competent Authorities
- Cooperation in vigilance and post-market activities
- Clear identification of the EU AR on product labelling
A compliant EU Authorised Representative is essential for legal market access in the European Union.
Our Process
Initial consultation
We assess your organisation, devices, and regulatory requirements.
Mandate agreement
We establish a formal EU AR mandate in line with EU MDR.
Documentation review
We review technical documentation and regulatory compliance.
Appointment and registration
We act as your EU AR and support EUDAMED registration.
Ongoing compliance support
We provide continuous regulatory and post-market support.
Industries We Support
We support EU Authorised Representative services across:
- Medical device manufacturers
- Digital health and SaMD companies
- Start-ups entering the EU market
- Global healthcare technology companies
Cost of Service
EU Authorised Representative Services for Medical Devices
Per Year
Ensure your smooth entry into the EU Medical Device market with an EUAR you can trust
Features
- CE Marking Compliance Support
- Official EU Authorised Representative
- Fast Onboarding
- Ongoing Regulatory Support
- Price includes unlimited number devices
Time Lines
Week 1 – Initial Review & Agreement
Assess your devices, confirm EU MDR requirements, and establish the EU Authorised Representative mandate
Week 2 – Documentation Verification & Setup
Review technical documentation, Declaration of Conformity, and ensure labelling compliance
Week 3 – Appointment & Ongoing Compliance
Formal EU AR appointment, EUDAMED support, and initiation of ongoing regulatory and vigilance support
One-Stop EU Importer & AR Solution
Navigating the dual requirements of Article 11 (Authorised Representative) and Article 13 (Importer) can be a significant hurdle for non-EU manufacturers. Under the MDR 2017/745 and IVDR 2017/746, the Importer is a distinct legal role with specific responsibilities, including verifying that the device is CE marked, correctly labeled, and accompanied by the required documentation.
By appointing Patient Guard Europe UG as both your EU Authorised Representative and your EU Importer, you benefit from a unified regulatory strategy:
- Simplified Labeling: Avoid the clutter of multiple company addresses on your packaging. We fulfill both roles, allowing for a single, professional point of contact to be listed on your product labels and Instructions for Use (IFU).
- Integrated EUDAMED Management: We manage both your AR and Importer registrations within EUDAMED (SRNs: DE-AR-000007523 and DE-IM-000025621), ensuring your Actor data is consistent and audit-ready.
- Reduced Supply Chain Friction: We act as your primary liaison with EU Customs and National Competent Authorities, ensuring that your shipments are verified quickly and comply with all Article 13 obligations without the need for a third-party logistics provider to take on regulatory liability.
- Cost-Effective Compliance: Managing both roles through Patient Guard eliminates the need for multiple service contracts and reduces the administrative overhead of coordinating between separate entities.
Frequently Asked Questions (FAQs)
What is an EU Authorised Representative?
An EU Authorised Representative is a legal entity established in the EU that acts on behalf of a non-EU manufacturer to ensure compliance with EU MDR.
Is an EU AR mandatory?
Yes, all non-EU manufacturers must appoint an EU Authorised Representative to sell medical devices in the EU. communication with authorities.
Where must the EU AR be based?
The EU AR must be established within the European Union.
What are the responsibilities of an EU AR?
Responsibilities include documentation verification, regulatory liaison, vigilance support, and ensuring ongoing compliance.
How long does it take to appoint an EU AR?
Appointment can typically be completed within 1–2 weeks depending on documentation readiness.
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