Trusted European Authorised
Representative Services for Global Compliance

As your appointed authorised representative, IMed EUAR acts as the essential legal link between your business and the European Competent Authorities. We provide the technical and regulatory oversight required to keep your medical devices and IVDs compliant with MDR and IVDR standards.

By choosing IMed as your EUAR, you ensure that patient safety and compliance integrity are prioritised and through access to our wider expertise and compliance services, ensure uninterrupted distribution across the European Union.

A Fully Compliant EUAR for Complete European Market Access

For manufacturers based outside the EU, appointing a European Authorised Representative is a legal requirement under the EU Medical Device and IVD Regulations. IMed Consultancy is a specialist EUAR with the technical depth to handle every aspect of your European representation. We offer proactive support,  clear communication and full visibility to ensure your European obligations are met.

As your European Authorised Representative, IMed will:

Maintain and verify your Technical Documentation and Declarations of Conformity

Register your devices with the relevant Competent Authorities and EUDAMED

Act as your primary point of contact for all European National Authorities

Support vigilance and post-market reporting requirements

Verify that the EU Declaration of Conformity and technical files are compliant

Advise on the latest MDR and IVDR updates affecting your products

We offer the regulatory precision and fast response times necessary to keep your business moving within the EU Single Market.

A gloved hand uses a dropper to carefully transfer a red liquid into one of many blood collection tubes organized in a white laboratory rack. The rack is filled with tubes capped in vibrant blue and orange, each containing a red fluid, set against a clean, neutral background.

Why Choose IMed EUAR as Your EU Rep?

Selecting the right authorised representatives is a critical strategic decision. IMed EUAR offers a partnership built on transparency, regulatory expertise, and commercial awareness. We provide independent EUAR services, ensuring your market access is never compromised by the conflicts of interest often found when using commercial importers as your representative.

By partnering with us for EU Rep services, you also benefit from:

  • Proven Experience: A team trusted by international MedTech and diagnostic innovators.
  • Impartial Representation: Independent advocacy focused purely on your compliance.
  • Regulatory Speed: Efficient documentation reviews and faster routes to market.
  • Direct Communication: Expert liaison with EU Competent Authorities.
  • Holistic Support: End-to-end guidance for MDR, IVDR, and international standards.

Frequently Asked EUAR Questions

Appointing an EU Authorised Rep involves delegating significant legal responsibilities. Here are some of the most common questions we receive regarding our representation services.

A European Authorised Representative (also known as an EC Rep) is a legal entity based in Europe appointed by a non-EU manufacturer. They act as the manufacturer’s representative toward EU authorities and ensure the device complies with EU regulations.

Yes. Both terms refer to the same role. Historically, EC Rep (European Community) was the standard term, while EU Rep or EUAR is more common under the current Medical Device Regulation (MDR).

Yes. As your European Authorised Representative, we manage the registration of your company and your devices within the EUDAMED database to ensure full transparency and compliance.

The timeline depends on the readiness of your technical documentation. IMed EUAR works efficiently to review your files and establish the mandate, ensuring your authorised representatives are in place as quickly as possible.

Partner with IMed EUAR

If you need a reliable European Authorised Representative, IMed EUAR provides the compliant and responsive EU Rep services you need to secure your market position. We ensure your devices remain compliant and protected across all EU member states.