YOUR PASSPORT TO EUROPEAN, UK, AND SWISS MARKETS

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.

The EU MDR and IVDR define several economic operator roles. Within this framework, the importer is assigned a crucial role, similar to the roles of the manufacturer, European authorized representative, and distributor. Simply put, an importer is a natural or legal person located within the Union territory that places a device from a third country on the Union market.

Among others, the EU IMP is obliged to verify that:

1. the device has been CE marked and that the EU declaration of conformity has been drawn up;
2. a manufacturer has been identified and an authorized representative has been designated by the manufacturer;
3. the device is labelled in accordance with the MDR and IVDR and comes with the required instructions for use;
4. a UDI has been assigned by the manufacturer.

The role of the importer cannot be formally mandated. It is a status that is acquired automatically as soon as a natural or legal person undertakes activities that fall within the definition of an importer, whether voluntarily or involuntarily. Often, parties are not aware of their obligations even though they have already become importers. Don't risk an interruption of your supply chain—partner with us to safeguard regulatory compliance with the applicable legislation and obligations.

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.