Ensure EU Market Access with a Trusted European Authorized R

 Your Compliance Partner for Seamless EU Market Entry
Choosing the right European Authorized Representative (EAR) is vital for ensuring that your medical or in-vitro diagnostic devices meet all regulatory obligations under MDR and IVDR. With deep regulatory expertise, we serve as your trusted liaison with EU authorities—maintaining technical documentation, supporting vigilance and FSCA reporting, and safeguarding your products’ compliance throughout their lifecycle. Partner with us to secure your place in the European market with confidence and clarity. 

Your Trusted European Authorized Representative – Guiding Your Compliance Every Step of the Way

Navigating the complexities of the European regulatory landscape can be daunting for medical device and in-vitro diagnostic manufacturers based outside the European Union. The appointment of a European Authorized Representative (EAR) is not merely a legal formality—it is a critical strategic decision that directly impacts your ability to access and succeed in the EU market under the stringent requirements of the Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746).

 At RAPS, we understand the full spectrum of responsibilities that come with acting as an EAR. Our team of regulatory professionals is equipped with deep expertise, practical experience, and a strong network of industry connections to support your business throughout the entire product lifecycle—from market entry to post-market surveillance and vigilance activities. 

As your designated EAR, we serve as your official point of contact with EU Competent Authorities and Notified Bodies. We take full responsibility for critical regulatory functions, including:

• Verifying the completeness and conformity of your technical documentation and EU Declaration of Conformity.
   
• Ensuring proper product labeling that includes the name and address of your EU representative, as required by law.
   
• Maintaining essential records and technical files for up to 15 years, readily available for inspection by EU regulatory authorities.
   
• Supporting complaint handling, incident management, and Field Safety Corrective Actions (FSCA) in close collaboration with you and your distribution network.
   
• Facilitating registration in EUDAMED and verifying Single Registration Number (SRN) compliance and updates.
   
• Providing immediate communication and feedback on complaints, adverse events, or regulatory issues raised by EU users or authorities.
   
• Terminating the mandate and informing regulatory authorities if your company fails to comply with the regulations.

We go far beyond administrative support—we become your compliance partner and advocate in the European market. Our proactive approach ensures you are always one step ahead of changing regulatory requirements, avoiding potential delays, penalties, or product recalls that can result from non-compliance.

Whether you're a startup bringing your first device to market or a multinational looking to streamline your EU operations, we tailor our services to meet your specific needs. We work closely with manufacturers of Class I, IIa, IIb, and III medical devices as well as in-vitro diagnostic devices across all risk categories. Additionally, for virtual manufacturers and OEM/OBL arrangements, we offer specialized support to ensure regulatory alignment between your documentation and that of your suppliers.

Our comprehensive mandate agreement clearly defines the scope of responsibilities, tasks, and obligations—offering full transparency and peace of mind. You remain the legal manufacturer, but we ensure that your compliance obligations are fully met, allowing you to focus on innovation and product development while we manage your regulatory footprint in Europe.

With [Your Company Name] as your EAR, you are not just appointing a regulatory contact—you are gaining a reliable, responsive, and knowledgeable partner committed to your long-term success in the EU. Let us help you build regulatory resilience, avoid costly compliance pitfalls, and enter the European market with confidence.

Partner with us today—because regulatory compliance is not optional, it’s foundational.

Your Strategic Compliance Partner for EU Representation – Built on Trust, Clarity, and Legal Precision

Establishing a robust and legally sound relationship between a non-EU medical device manufacturer and their European Authorized Representative (EAR) is more than a regulatory formality—it is a cornerstone of your compliance strategy. The EU Representative Agreement and Mandate Document are not just paperwork; they are the legal frameworks that bind your company’s access to the EU market with the representative who will act on your behalf before regulatory authorities, notified bodies, and other stakeholders.

At [Your Company Name], we specialize in crafting precise, MDR- and IVDR-compliant agreements that protect your interests while fulfilling all obligations outlined in Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Our agreements and mandates are designed to withstand regulatory scrutiny and ensure seamless cooperation across every aspect of your product’s EU lifecycle.

• Comprehensive Role Definition: Clear articulation of both parties’ responsibilities, including technical documentation management, vigilance reporting, incident handling, and communication with competent authorities.
   
• Mandate Authority: A legally binding mandate empowering us to act on your behalf with EU regulators and maintain required documents such as the Declaration of Conformity and CE certificates for up to 15 years.
   
• Confidentiality & Data Protection: Robust clauses to ensure the security of your technical files, IP, and commercial data.
   
• Liability Clauses: Definitions of responsibility and accountability, including joint liability provisions per Article 11 of the MDR and IVDR in case of non-compliance.
   
• Change Management Procedures: Detailed protocols for termination, renewal, and reassignment of representation—ensuring no interruption in your EU compliance status.

Changing your EU Authorized Representative must be done with care. Article 12 of the MDR and IVDR mandates that all stakeholders—including the outgoing and incoming EARs—should agree to the transition plan. Our team supports you throughout this process with:

• Contractual Coordination: Facilitating tri-party agreements between the manufacturer, outgoing EAR, and [Your Company Name] as the incoming EAR, defining obligations before and after the handover.
   
• Regulatory Notifications: Prompt updates to Competent Authorities and Notified Bodies, ensuring no delay in certifications, registrations, or market access.
   
• Documentation Transfer: Secure migration and validation of all technical files, vigilance records, PMS and PMCF documentation, and labeling.
   
• Labeling & Packaging Support: Updating your product labels to reflect the new EAR’s name and address, as required under MDR and IVDR.
   
• EUDAMED Updates: Ensuring accurate Single Registration Number (SRN) transfer and database integrity during the switch.

Your partnership with us doesn’t end at designation. We continuously monitor evolving EU legislation and provide proactive guidance to ensure your products remain fully compliant. Our support includes:

• Reviewing and advising on Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), and Periodic Safety Update Reports (PSUR).
   
• Coordinating incident management and Field Safety Corrective Actions (FSCA) with your supply chain partners and EU authorities.
   
• Ensuring traceability of distributors and importers under Article 25 of MDR/IVDR.
   
• Representing your interests during inspections, audits, or market surveillance investigations.
   

We are more than just a registered EU address. We are strategic advisors, regulatory stewards, and your permanent link to EU compliance. Our experience spans across Class I to Class III medical devices and all risk classes of IVDs. With a proven track record of helping global manufacturers enter and grow in the EU market, our services are tailored, transparent, and always focused on long-term compliance and business success.