European Authorized Representative

Reliable European Authorized Representative Services for Medical Device Compliance and Market Access

Navigating the European medical device market requires expert guidance, especially when it comes to compliance with the Medical Device Regulation (MDR) 2017/745. That’s where a European Representative comes into play. Acting as your liaison, they are your bridge to successfully entering and staying compliant within the EU market.

Firstly, a European Representative plays a crucial role in ensuring that your medical devices meet all the necessary regulatory requirements of the MDR. They are your on-ground partner, providing vital support in navigating the complex regulatory landscape of the EU.

Moreover, they assist in communicating with the European Union’s regulatory bodies. This includes handling all necessary documentation and registrations, ensuring that your device’s journey to the market is smooth and uninterrupted. Their in-depth understanding of the MDR means they can offer tailored advice, helping you avoid common pitfalls that could delay your market entry.

Additionally, should there be any issues or incidents with your device, your European Representative acts swiftly to report these to the relevant authorities, ensuring that all regulatory obligations are met promptly and efficiently.

In essence, a European Representative is indispensable for medical device manufacturers outside the EU. They not only facilitate your entrance into the European market but also ensure ongoing compliance, safeguarding your device’s presence in the market. With their expertise, you can focus on what you do best: innovating and providing high-quality medical devices to those who need them most.

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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