EU Authorized Representative (EU Rep) Services
Expand Your Reach to Europe with Confidence
MedQCompliance, in collaboration with our trusted European partner, now offers EU Authorized Representative (EU Rep) services to support medical device manufacturers based outside of the European Union.
If you are a non-EU manufacturer looking to market your medical devices in the EU, the law requires you to appoint a qualified EU Authorized Representative. We make this process seamless, ensuring full compliance with the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) requirements.
What is an EU Authorized Representative?
An EU Authorized Representative (EU Rep) is a legal entity based within the European Union who acts on behalf of a non-EU manufacturer to ensure compliance with European regulations. The EU Rep serves as your official contact point for European authorities and plays a critical role in regulatory communications and vigilance activities.
Why Do You Need an EU Authorized Representative?
Under the EU MDR and IVDR, non-EU manufacturers must appoint an EU Authorized Representative to:
- Legally place their medical devices on the European market
- Ensure continued regulatory compliance within the EU
- Provide a clear channel of communication with EU Competent Authorities
- Meet post-market surveillance and vigilance obligations
Without a designated EU Rep, your medical devices cannot be legally marketed or distributed in the EU.
Roles and Responsibilities of the EU Authorized Representative
Our EU Rep partner will
- Verify your Technical Documentation and EU Declaration of Conformity
- Ensure registration of your devices in the EUDAMED database
- Serve as your primary point of contact for EU Competent Authorities
- Assist in incident and complaint reporting obligations
- Keep copies of relevant compliance documentation available for inspection
- Cooperate with authorities during audits, inspections, or corrective actions
- Terminate the mandate if you fail to meet regulatory obligations
Partner with MedQCompliance to simplify your entry into the European market with reliable and compliant EU Rep services.
Contact us today to learn how we can help you navigate European regulatory requirements with ease.
Frequently Asked Questions
Get quick answers to common questions about MedQ Compliance’s services and Medtech regulatory consulting.
You can connect with us through our website, LinkedIn, Google search, or referrals to schedule an initial consultation.
MedQ Compliance specializes in preparing a tailored regulatory strategy for your medical device solution, support in building technical documentation and completing regulatory submissions in global markets such as US FDA, EU MDR/ IVDR, CDSCO India, Singapore HSA, and other countries.
MedQ Compliance prioritizes confidentiality, implementing secure processes for information protection.
Timelines for regulatory approvals depend on multiple factors such as completeness of the technical dossier, meeting applicable requirements and timely communication with the regulatory bodies. MedQ Compliance optimizes all these key areas that ensure high efficiency and minimal timelines for regulatory clearances.