Exploring the complex landscape of EU regulations for medical devices and in-vitro diagnostic devices can be daunting. That’s where an EU Authorized Representative (EU AR) comes in—a crucial partner for non-EU-based MedTech companies looking to enter and sustain their presence in the European market. Here’s how partnering with an experienced EU AR can streamline your compliance efforts, reduce risks, and keep your devices on the market.

Key Responsibilities of an EU Authorized Representative

An EU Authorized Representative is a legal entity designated by a non-EU manufacturer to act on their behalf in ensuring regulatory compliance. Here are the critical tasks an EU AR handles:

1. Regulatory Documentation Verification: The EU AR verifies that your company has prepared all the required technical documentation and EU declarations of conformity. This includes ensuring that the appropriate conformity assessment procedures have been carried out.

2. Document Storage & Access: They maintain copies of essential compliance documents, such as technical files, declarations of conformity, and certificates. These must be accessible to competent authorities upon request.

3. EUDAMED Registration: The representative ensures that your device information is accurately registered in the EUDAMED database—a requirement under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

4. Compliance & Corrective Actions: They liaise with authorities on preventive and corrective actions, especially in cases of recalls or adverse events. The EU AR also alerts manufacturers to complaints and any requests for device samples by authorities.

5. Shared Liability: Under MDR and IVDR, the EU AR shares liability with the manufacturer if the latter fails to meet regulatory obligations and is not located within the EU. This makes choosing a reliable and experienced partner essential for mitigating risks.

The Arazy Group Advantage: A Trusted Partner with 27+ Years of Experience

With over 27 years of experience in regulatory affairs, Arazy Group stands out as one of the most seasoned firms in the industry. We have deep expertise in working with competent authorities across Europe, including the UK’s MHRA, Germany’s BfArM, and Ireland’s HPRA.

Here’s why Arazy Group is your best option:

• Global Reach with Local Support: Operating in 140 countries worldwide, Arazy Group offers localized support tailored to your region, language, and time zone. This ensures swift responses, especially in critical situations like recalls or adverse incident reporting.

• One-Stop Regulatory Solution: We provide comprehensive EU AR, UK Responsible Person, and Swiss Representative services, simplifying your compliance journey. Our online platform, LICENSALE®, streamlines the entire process—allowing you to efficiently store, manage, and share your compliance documentation.

• Proven Track Record in the UK Market: Our UK offices have been supporting MedTech companies since 1996, acting as an established UK Responsible Person. We also offer EU AR services through our German and Irish offices, supporting manufacturers of all types of medical and IVD devices.

How Arazy Group Can Help You Stay Compliant and Competitive

Partnering with Arazy Group means leveraging our robust regulatory infrastructure and decades of experience. Whether you're looking to enter the EU, UK, or Swiss markets, our dedicated team and advanced technology solution, LICENSALE®, provide the expertise you need to maintain compliance and ensure continuous device placement in the market.

Don’t let regulatory hurdles slow down your MedTech innovation. Reach out to Arazy Group to learn more about our EU Authorized Representative services and how we can support your compliance needs today.