Seize Global Opportunities with Ease: Your Trusted Representative for the EU, UK, and Switzerland
In today’s dynamic landscape, medical device and IVD manufacturers face evolving regulations that can quickly turn market entry into a maze of paperwork and ever-changing rules. For non-resident companies, merely keeping track of different guidelines for Europe, the UK, and Switzerland can devour valuable time and resources. But it doesn’t have to be that way. Our all-inclusive Representative Services take the guesswork out of compliance, ensuring a streamlined pathway to each target market. Let us shoulder the complexities so you can focus on delivering the innovative solutions patients and healthcare providers rely on.
Your One-Stop Solution for Expert Representative Services
Whether you’re entering the European Union, preparing for the UK market, or aiming to comply with Swiss regulations, we stand ready to serve as your dedicated partner. Our portfolio of services includes:
- EU Authorised Representative (EC REP) – Seamlessly comply with EU regulations, including the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
- UK Responsible Person (UKRP) – Efficiently fulfil obligations under the UK regulatory framework while positioning your devices for success in the British market.
- Swiss Authorised Representative (CH-REP) – Navigate Swiss-specific requirements, guaranteeing continuous market access and compliance in Switzerland.
Empower Your Global Growth with Risk-Free Compliance
By partnering with us, you gain:
- Expert Guidance – Our team of seasoned professionals stays up to date with the latest regulatory changes, ensuring your devices remain compliant and competitive.
- Streamlined Processes – We handle the intricate details—documentation, labelling review, post-market surveillance—so you can focus on innovation and growth.
- Reduced Risk – Proactive monitoring and efficient resolution of compliance challenges minimize the risk of costly delays or penalties.
- Peace of Mind – With our full-service support and local market insights, you’ll have a trusted ally that helps your product thrive in new territories.
Secure Your International Success—Contact Us Today!
Take the first step toward successful expansion into Europe, the UK, and Switzerland. Contact us today to discover how our Representative Services can protect your interests, ensure regulatory compliance, and accelerate your product launch. Let us help you chart a clear path to international success—your journey starts here.
GET STARTED NOWGlobal Network, Unrivalled Expertise: Your Trusted Representative for Medical Devices & IVDs
Leverage the power of over 30 years of industry experience and a worldwide presence in more than 90 countries. Our comprehensive Representation Services are fuelled by an extensive partner network, ensuring seamless, on-the-ground support across multiple markets. With a deep understanding of evolving regulations and best practices, we provide the personalized guidance you need to navigate each territory’s unique challenges. Whether you’re expanding into the EU, the UK, Switzerland, or beyond, our proven track record and dedication to quality will position your products for success—every step of the way.
We'll be more than happy to answer any questions you might have.
Contact us today for a free no-obligation consultation.
Frequently Asked Questions
An EC Rep is a legal entity based in the EU that acts on behalf of non-EU manufacturers to ensure compliance with EU regulations (MDR/IVDR). By appointing an EC Rep, you gain direct access to the EU market without needing a physical presence in Europe.
The EU requires a local point of contact within its borders for regulatory correspondence and vigilance activities. Having a professional EC Rep streamlines communication with EU authorities and keeps you updated on regulation changes, minimizing risk and delays.
A UKRP ensures that your medical devices and IVDs meet UK regulatory requirements, including device registration, labelling compliance, and post-market surveillance. This enables you to maintain uninterrupted market access in the UK and focus on product innovation.
Yes. The EU and UK regulatory frameworks are separate post-Brexit. Appointing both an EC Rep and a UKRP ensures you meet each region’s unique requirements, maintaining full compliance and market coverage.
A CH-REP is a regulatory representative established in Switzerland. This entity manages local regulatory compliance, labelling, and post-market obligations for non-Swiss manufacturers. Engaging a CH-REP guarantees seamless market entry and ongoing compliance in Switzerland.
We take on the heavy lifting—monitoring local requirements, preparing documentation, and liaising with authorities—reducing your administrative burden. This focus on compliance allows you to devote more time to core business activities.
Absolutely. Our Representative Services include thorough review of labelling to ensure it meets regional regulatory standards. We also manage device registrations, saving you time and decreasing the risk of costly mistakes.
We set up robust PMS systems, track device performance, and submit necessary reports to competent authorities. This proactive approach mitigates potential issues and safeguards patient safety and your brand reputation.
We act on your behalf, promptly responding to inquiries, scheduling audits, and coordinating any required documentation. This ensures compliance issues are addressed swiftly, minimizing disruptions.
Our dedicated team of experts continually monitors updates in EU, UK, and Swiss regulations. By staying on top of new requirements, we help you adapt quickly, preventing surprises and ensuring your devices remain compliant.
We conduct periodic compliance audits, maintain close communication with your team, and ensure continuous updates to technical documentation and labelling. These measures prevent regulatory gaps and potential penalties.
As your representative, we coordinate all necessary actions with local authorities, distributors, and users. We ensure transparent, timely communication that protects patient safety and your company’s reputation.
Yes. Our multi-faceted approach allows us to manage EC Rep, UKRP, and CH-REP services for various device classes and IVDs simultaneously. You gain a centralized point of contact for global compliance.
We offer tiered service packages tailored to your device portfolio, risk classification, and geographic scope. This approach ensures cost transparency and helps you optimize your investment in compliance.
Reach out through our website or contact us directly. We’ll assess your specific requirements, recommend an appropriate service package, and guide you step-by-step as you expand into new markets confidently and seamlessly.