EU Authorised Representative (EU AR) Services – Medical Devices & IVD Compliance
For manufacturers outside the European Union, appointing an EU Authorised Representative (EU AR) is a legal requirement under the EU Medical Device Regulation (EU MDR) and EU In Vitro Diagnostic Regulation (EU IVDR). At MedTech Consultancy, we provide expert EU AR services that support compliance, CE marking, and ongoing regulatory obligations within the EU.
Whether you’re expanding into European markets for the first time or managing compliance for multiple products, our EU AR services ensure your regulatory obligations are fulfilled with confidence and clarity.
What Is an EU Authorised Representative (EU AR)?
An EU Authorised Representative is a legal or natural person established within the European Union who acts on behalf of a manufacturer located outside the EU.
Under EU MDR and EU IVDR, the EU AR:
✔ Acts as the official contact point for EU regulatory authorities
✔ Ensures your product’s compliance with applicable EU requirements
✔ Maintains access to technical documentation for inspection
✔ Helps facilitate postmarket surveillance and vigilance reporting
Manufacturers without a physical EU base must appoint an EU AR before placing medical devices or IVDs on the European market.
Why EU AR Services Matter
Appointing an EU AR is required by law and serves several critical functions:
✔ Enables lawful market access in the EU
✔ Ensures regulatory accountability and traceability
✔ Provides a local regulatory partner for authorities
✔ Supports audit readiness and documentation availability
Without an EU AR, manufacturers risk:
❌ Inability to legally sell products in the EU
❌ Increased compliance risk and potential enforcement
❌ Delays or barriers to CE marking and market entry
Who Needs an EU Authorised Representative?
EU AR services are necessary for:
✔ Non-EU manufacturers planning to sell devices in the EU
✔ Organisations without an EU establishment
✔ Medical device and IVD companies seeking EU market access
✔ Regulatory teams needing support with EU compliance obligations
If your headquarters are outside the EU, appointing an EU AR is mandatory before placing products on the European market.
Our EU Authorised Representative Services
At MedTech Consultancy, we offer comprehensive EU AR support, including:
EU AR Appointment & Agreement
We act as your EU Authorised Representative under applicable regulations.
CE Marking Support & Regulatory Liaison
We support CE marking processes and act as the main point of contact with EU regulatory authorities.
Documentation Maintenance & Accessibility
We ensure that your technical documentation and regulatory files are available for inspection by EU authorities.
Vigilance & PostMarket Surveillance Support
We help manage vigilance reporting and postmarket compliance obligations in the EU.
Regulatory Updates & Compliance Monitoring
We monitor changes in EU MDR/EU IVDR requirements and keep your compliance strategy up to date.
Benefits of Our EU AR Services
🔹 Legal compliance in the EU
Appointing a compliant EU AR ensures you can legally place products on the European market.
🔹 Local regulatory representation
We act as your regulatory partner within the EU for authorities and audits.
🔹 Ongoing compliance support
We monitor changes to EU MDR and help you adapt your regulatory strategy.
🔹 Reduced administrative burden
We manage regulatory communication, documentation access, and vigilance activities.
How We Work
- Initial consultation
Review your products, regulatory goals, and EU entry strategy. - EU AR appointment agreement
Formalise our role as your appointed EU Authorised Representative. - Documentation setup & maintenance
Ensure regulatory documentation is compliant and accessible. - Ongoing regulatory support
Monitor EU regulatory changes, manage vigilance reporting, and liaise with authorities.
Why MedTech Consultancy
✔ Deep regulatory expertise in EU MDR and EU IVDR
✔ Practical, compliant representation for nonEU manufacturers
✔ Endtoend support for CE marking and postmarket obligations
✔ Transparent, clientfocused process