Authorized Representative Medical Devices (EC-REP)

• Due Diligence: We start by reviewing the manufacturer’s regulatory, quality, legal, and technical documentation. This step is crucial to ensure compliance from the start.  
• EUDAMED Compliance: We verify and maintain compliance with EUDAMED requirements.
• Fast, easy and compliant onboarding helps you avoid delays.

• Vigilance Reporting: We support manufacturers with reporting serious incidents, trend reports, periodic summary reports, and field safety corrective actions, mitigating risks and ensuring timely compliance with EU regulations.
• Regulatory Communication: Acting as the main contact between the manufacturer and EU Competent Authorities, we manage all communications and address regulatory queries by collaborating with the manufacturer.
• Annual Check-in: Each year we will verify documentation updates, safety reporting, and other information to ensure continued compliance.
• Documentation Management: Lumis securely stores and archives relevant technical and regulatory documentation, ensuring easy access for authorities.
• Additional Services: we can provide additional services such as applying for certificates of free sale and submitting applications to notified bodies.

• If needed, we handle project closeout, including archiving documents for the duration required by the MDR/IVDR.
• Vigilance responsibilities – we may continue some vigilance activities beyond mandate closure to ensure ongoing compliance.

We perform all necessary activities under Article 11 (3) (a-h) of the MDR/IVDR, ensuring complete EU regulatory compliance.

Need more support with EU medical device regulatory compliance? Lumis offers consultancy for CE-marking and post-market activities. Whether this be preparing technical documentation, clinical evaluation reports, or quality management system support, we can help. Check out our consultancy here.