If you are a non-EU manufacturer looking to market your products in the European Union, appointing an EU Authorised Representative (EU AR) is a legal requirement under various EU regulations, including EU GPSR (General Product Safety Regulation), MDR (Medical Device Regulation), IVDR (In Vitro Diagnostic Regulation), and CE Marking Directives.
Our EU Authorised Representation services provide a seamless pathway for non-EU companies to meet regulatory obligations and gain access to the European market.
We ensure that your products comply with all necessary EU regulations. As your liaison with European authorities, we manage communication and keep you informed about regulatory updates and changes.
By appointing us as your EU Authorised Representative, you fulfill the legal requirement to sell your products within the EU, ensuring smooth entry into the European market.
With our in-depth knowledge of EU regulations and compliance strategies, we provide tailored advice and continuous support to navigate the complexities of the European regulatory landscape.
As your EU AR, our registered European address can be used on product labels and technical documentation for all official communications with authorities.
We offer continuous assistance with regulatory updates, compliance monitoring, and interactions with EU authorities, ensuring your business remains compliant at all times.
We act as your official representative in the EU, ensuring that your company meets the legal requirements for selling products within the European market.
We securely hold and maintain your product’s technical documentation, ensuring it is readily available for EU regulatory authorities upon request.
We liaise with EU authorities regarding any incidents, adverse events, or product recalls, ensuring swift action and compliance with reporting obligations.
We continuously monitor regulatory updates and ensure your products adhere to all applicable EU regulations, keeping you informed about any necessary changes.
We verify that your product labels and accompanying documentation meet all EU requirements, avoiding compliance issues that could delay market entry.
We assist with post-market surveillance obligations, including periodic safety updates and reporting adverse incidents as required by EU law.
We act as your point of contact for EU market surveillance authorities, helping to resolve any compliance-related inquiries efficiently.
Ensure seamless access to the European market with our professional EU Authorised Representation services. We make compliance simple and stress-free.
Don’t let regulatory requirements stand in the way of your success.
Contact us today to learn how we can support your compliance journey and help you establish a strong presence in the European market.