Authorised representation services for medical device and IVD manufacturers
Abingdon AI & MedTech
Authorised representation
Expanding into new markets requires more than regulatory approval alone. Manufacturers must also appoint the appropriate local regulatory representative to maintain compliance and provide a recognised point of contact for in-country regulatory authorities. Abingdon AI & MedTech provides US Agent services, EU Authorised Representative (EUAR), and UK Responsible Person (UKRP) with an established track record.
At a glance
Representation Services at a Glance
US Agent
United States: FDA communications and regulatory liaison
EU Authorised Representative
European Union: regulatory representation under MDR & IVDR
UK Responsible Person
Great Britain: MHRA registration and compliance support
What we deliver
Representation services
US Agent
For overseas manufacturers supplying products to the United States, a US Agent is required for FDA communications and regulatory correspondence. Abingdon AI & MedTech provides US Agent services for medical device and IVD manufacturers, acting as a liaison with the FDA and supporting efficient communication throughout registration, submission and post-market activities. Our experienced team navigates US regulatory requirements with ease.
EU Authorised Representative (EUAR)
An EU Authorised Representative plays a key role in maintaining access to the European market. Acting on behalf of non-EU manufacturers, we support communication with regulatory authorities, maintain required documentation and help organisations understand their responsibilities under EU MDR and IVDR. Our goal is to provide a reliable regulatory presence that supports long-term compliance and market continuity.
UK Responsible Person (UKRP)
Manufacturers located outside the UK require a UK Responsible Person to place medical devices and IVDs on the market in Great Britain. Abingdon AI & MedTech provides UKRP services to support product registrations, regulatory communications and compliance activities. We act as a trusted extension of your regulatory team, managing registrations, responding to regulatory enquiries and maintaining ongoing compliance with MHRA requirements.
Global Market Access Support
We also support medical device developers and manufacturers planning expansion into other international markets. Our regulatory specialists help organisations understand country-specific registration, in-country representation and market access requirements in over 90 global territories, coordinating with trusted local partners where necessary. This enables manufacturers to develop a clear and compliant strategy for global commercialisation while keeping a single point of contact for regulatory guidance.
Our approach
Are You Correctly Represented?
Choosing a regulatory representative is about more than meeting a legal requirement. You need a partner who understands your products and global regulatory requirements, responds quickly to regulatory requests and helps reduce the burden of maintaining compliance across multiple markets. Our team supports diagnostics and MedTech companies throughout the product lifecycle, combining regulatory expertise with broad experience across development, quality management systems and commercialisation activities.
From the Knowledge Centre
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Frequently asked questions
Authorised representation FAQs
An EU Authorised Representative (EUAR) is a legal representative appointed by non-EU medical device and IVD manufacturers to support compliance with EU MDR and IVDR requirements. The EUAR acts as a point of contact for competent authorities and helps maintain market access within the European Union.
Manufacturers located outside the UK require a UK Responsible Person (UKRP) to place medical devices and IVDs on the market in Great Britain. The UKRP supports product registration, regulatory communications and ongoing compliance with MHRA requirements.
A US Agent acts as a regulatory liaison between overseas manufacturers and the FDA. US Agent services support FDA communications, regulatory correspondence and ongoing regulatory activities for manufacturers supplying products to the United States.
A US Agent supports FDA communications for the United States, an EU Authorised Representative supports compliance under EU MDR and IVDR, and a UK Responsible Person supports regulatory requirements in Great Britain. The specific role depends on the target market and manufacturer location.
Yes. Authorised representation services can support compliance, regulatory communications and market access across the United States, European Union, Great Britain and other international territories. These services help manufacturers maintain regulatory obligations while expanding into new markets.
Manufacturers should select a representative with experience in medical devices, IVDs and applicable regulatory requirements. A knowledgeable representative can help support compliance activities, regulatory communications and long-term market access objectives.
Start the conversation
Find out more about our in-country rep services
Whether you are preparing for your first international product launch or expanding into new territories, Abingdon AI & MedTech can provide the regulatory representation services needed to support compliance and market access. Speak with our team to discuss your requirements and identify the right route for your products.
- US, EU and UK market access
- ISO 13485, MDR, IVDR and FDA expertise
- Flexible support models