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.
- (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
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.
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.
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.
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.
The directives and standards we work with
Each recommendation ties back to a specific directive, annex, or harmonised standard.
| Regulation | Number | Scope |
|---|---|---|
| Medical Device Regulation | (EU) 2017/745 | Medical devices placed on the EU market |
| PPE Regulation | (EU) 2016/425 | Personal Protective Equipment |
| General Product Safety Regulation | (EU) 2023/988 | Consumer products not covered by sector legislation |
| Radio Equipment Directive | 2014/53/EU | Products with wireless functionality |
| Market Surveillance Regulation | (EU) 2019/1020 | Economic operator obligations for all CE-marked products |
Often delivered together
These services are commonly scoped as part of a single engagement.
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.
