Compliance Partner for Non-EU Manufacturers.
For companies based outside the European Union seeking to place regulated products on the European market, a competitive product alone is not enough. They also need a reliable presence in the EU and a compliance framework capable of withstanding regulatory scrutiny. This is exactly what we provide – acting as your EU Authorised Representative (EU-REP) and offering practical regulatory support to ensure secure and sustainable market access.
We support manufacturers, brand owners and cross-border online retailers established outside the EU – particularly in highly regulated sectors such as medical devices and medical technology, as well as in other industries subject to lifecycle compliance obligations. Depending on the product category, target markets and applicable EU legislation, we act as your EU Authorised Representative or Responsible Person.
Our services include:
- Regulatory assessment prior to market entry
- Review of labelling, packaging and technical documentation
- CE compliance support as well as GPSR, MDR, IVDR and cosmetics compliance
- EPR, Packaging Act/LUCID, WEEE and EU Batteries Regulation compliance
- Communication with market surveillance authorities
- Risk mitigation in the event of regulatory non-compliance, recalls and corrective actions
Whether you are entering the European market for the first time or already selling through TikTok, Temu, OTTO and traditional distribution channels, we provide tailored support. We identify the regulatory requirements applicable to your products, prepare the necessary documentation and establish an audit-ready compliance framework.
Compliance Made EU-Ready
What we help you To achieve
Establish EU representation with a clear mandate. We set up a compliant EU Authorised Representative relationship with defined roles, responsibilities, and communication routes.
Create and maintain EU-ready documentation and labelling We support the availability, consistency, and controlled handling of required documentation, including change control, version management, and record traceability.
Reduce friction with EU stakeholders. We enable efficient, professional communication with EU competent authorities and other economic operators through structured escalation paths and response procedures aligned with the mandate.
Support market access and lifecycle compliance. We support you from onboarding and market entry through ongoing activities such as product updates, vigilance-related coordination, and post-market routines, based on your product scope and regulatory pathway.
How we work
Our approach is structured, transparent, and designed for long-term continuity.
Initial consultation and scope definition
We review your product portfolio, intended EU markets, and current compliance status. We clarify expectations, responsibilities, and practical next steps.
Onboarding and mandate set-up
We establish the EU-REP mandate and define contacts, responsibilities, and response routes. We also set up the working model for day-to-day cooperation, including document exchange, change notifications, and escalation rules.
Documentation readiness and process alignment
We align documentation availability and update routines with EU expectations. Where needed, we implement simple, auditable processes for records management and controlled documentation handling.
Ongoing representation and compliance support
We provide day-to-day authorised representative services and ongoing support across the product lifecycle, including structured communication and coordination with relevant EU stakeholders, within the agreed scope and mandate.
Why clients choose us
- EU-based presence supported by structured, auditable processes
- Clear deliverables and transparent scope
- Practical regulatory expertise focused on workable solutions and lifecycle continuity
- Confidentiality-first cooperation and secure handling of controlled documentation
- Professional communication with defined response routes and escalation handling
- For efficient coordination across regions and stakeholders, we provide support in German, English, Chinese, and Russian.
