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AMS Consultants
A trusted, collaborative extension of your business

EU, UK and Global Representation

Expanding your product into international territories requires far more than just technical compliance; it requires a physical and legal presence. For manufacturers based outside the target region, appointing a local representative is a strict legal mandate.

Applicable regulation
  • (EU) 2017/745Medical Device RegulationMedical devices placed on the EU market
  • (EU) 2016/425PPE RegulationPersonal Protective Equipment
  • (EU) 2023/988General Product Safety RegulationConsumer products not covered by sector legislation
What is it?

EU, UK & Global Representation, explained.

Expanding your product into international territories requires far more than just technical compliance; it requires a physical and legal presence. For manufacturers based outside the target region, appointing a local representative is a strict legal mandate, yet handing over your technical documentation and regulatory liability requires immense trust. We understand the vulnerability involved in this process and treat your compliance as if it were our own. While we serve as your legally mandated EU Authorised Representative from our Malta headquarters, we also coordinate UK Responsible Person and US FDA US Agent services, ensuring concurrent, seamless access to the world's largest markets. We do not just hold your technical files; we act as a trusted, collaborative extension of your business. Taking absolute ownership of your regulatory front line, we handle all communication with market surveillance authorities. Through our adaptability, we scale our specialist network to meet any international representation challenge, defending your interests with integrity and allowing your team to focus entirely on global growth.

The process

How we deliver this service

A structured sequence runs behind every project so nothing is missed and the deadline stays in sight from day one.

01

Technical Correctness

While we serve as your legally mandated EU Authorised Representative from our Malta headquarters, we also coordinate UK Responsible Person (UKRP) and US FDA US Agent services, ensuring concurrent, seamless access to the world's largest markets.

02

AMS Values

We do not just hold your technical files; we act as a trusted, collaborative extension of your business. Through our adaptability, we scale our specialist network to meet any international representation challenge, defending your interests with integrity.

Applicable regulation

The directives and standards we work with

Each recommendation ties back to a specific directive, annex, or harmonised standard.

RegulationNumberScope
Medical Device Regulation(EU) 2017/745Medical devices placed on the EU market
PPE Regulation(EU) 2016/425Personal Protective Equipment
General Product Safety Regulation(EU) 2023/988Consumer products not covered by sector legislation
Radio Equipment Directive2014/53/EUProducts with wireless functionality
Market Surveillance Regulation(EU) 2019/1020Economic operator obligations for all CE-marked products
Next step

Get a realistic timeline for your eu, uk & global representation project

In this 20-minute call, you will receive a list of applicable directives, likely testing needs, and clear next steps.