European Authorized Representative

In the often complex and ever-changing landscape of European regulatory affairs, Sobel Consultancy steps in as your trusted European Authorized Representative, serving as an essential link between foreign medical device manufacturers and the European Union. With deep-rooted expertise in EU MDR and CE marking for medical devices, our services are designed to navigate the labyrinthine rules and procedures with precision and efficiency.

Our representation ensures your products meet the stringent regulatory standards, fostering seamless market access. When you engage Sobel Consultancy, you receive more than a representative; you gain a dedicated partner committed to ensuring your regulatory compliance, thereby safeguarding your brand's reputation and market position.

Why do you need this service?

Every manufacturer that has no legal entity within the European Union, needs an authorized representative within the EU. Sobel has the necessary legal structure in place.

In case your product causes a vigilance case, we will handle this in a professional and effective manner. We help you to gather the required information and communicate with the authorities.

Your business growth and you need support for more complex services? Complete regulatory, biological and clinical evaluation? We are at your side and handle even difficult request.

Looking for European Authorized Representation assistance?

If you are looking for a European Authorized Representative for your medical devices as per MDR 2017/745, Sobel can provide you with everything you need to get your business running in the European Union.

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