Professional European Authorized Representative Services for US Medical Device Manufacturers
Your Trusted European Authorized Representative (EC REP) for EU MDR & IVDR Compliance
Accelerate your entry into the European market. Nometech provides professional, senior-level representation for US medical device manufacturers, ensuring your products remain compliant and market-ready.
How we can help
Comprehensive Representation for Global Success
For US-based manufacturers, the transition to EU MDR (2017/745) and IVDR (2017/746) has introduced unprecedented complexity. Without a physical presence in the EU, you are legally required to appoint an Authorized Representative (EC REP) to act as your primary liaison with European Competent Authorities.
Choosing a “mailbox service” isn’t enough anymore. You need a partner who understands the technical and clinical nuances of your device.
Flexible Representation Model
Our EC REP service is designed to scale with your European presence. Whether you are launching your first device or managing a complex portfolio, we adapt our level of regulatory oversight to match your internal capabilities, ensuring seamless compliance without unnecessary friction.
As your European Authorized Representative, Nometech ensures your medical devices meet all regulatory requirements
We don’t just provide an address; we provide a robust regulatory shield.
Official Regulatory Liaison: We act as your legal representative toward EU Member States and Competent Authorities.
Technical Documentation Review: Our senior experts verify your Technical File and Declaration of Conformity to ensure they meet Annex II & III requirements before market entry.
EUDAMED Management: We handle your actor registration and ensure your device data is accurately maintained in the EUDAMED database.
Vigilance & Incident Reporting: We provide support for reporting serious incidents and coordinating Field Safety Corrective Actions (FSCA).
PRRC Support: Our team can provide or support your Person Responsible for Regulatory Compliance (PRRC) to meet Article 15 requirements.
Expert-to-Expert Partnership
Deep RA/QA Expertise: Our consultants are veterans in ISO 13485, Risk Management (ISO 14971), and Clinical Evaluations.
US-EU Bridge: We understand the FDA 510(k)/PMA mindset and help you “translate” your existing documentation into the EU MDR format.
Fast & Responsive: We operate with the speed your business demands. No bureaucratic delays, just direct expert communication.
Ready to Expand to Europe?
Don’t let regulatory hurdles slow down your global growth. Contact our Finland-based team today to discuss your EC REP needs.