Expert IVD Regulatory Support for European Markets
Navigate IVDR complexities with confidence
Specialized regulatory expertise for in vitro diagnostic manufacturers. Our deep understanding of IVDR requirements and established relationships with competent authorities ensure smooth market access across EU, UK, and Switzerland.
Specialized IVD Regulatory Expertise
Navigate the complex world of in vitro diagnostic regulations with confidence
IVDR Specialization
Deep expertise in In Vitro Diagnostic Regulation (IVDR) 2017/746 with proven track record in complex IVD classifications.
→EUDAMED Integration
Comprehensive support for EUDAMED database registration and ongoing maintenance for IVD products.
→Legal Representative
Support for IVD performance evaluation studies. CRO and competent authority communication.
→Competent Authority Liaison
Established relationships with competent authorities specializing in IVD conformity assessments and certifications.
→Vigilance System
Complete post-market surveillance for IVD adverse events, and field safety corrective actions.
→Free Sales Certificates
Application for Free Sales Certificates, Embassy legalisation, and Apostille Services.
→IVDR Article 11 - Authorized Representative Requirements
Understanding your legal obligations under IVDR
Mandatory Appointment
Non-EU manufacturers must designate a sole authorized representative before placing IVDs on the Union market.
Written Mandate
The designation must be accepted in writing by the authorized representative and be effective for all devices of the same generic group.
Competent Authority Access
The authorized representative must provide mandate copies to competent authorities upon request.
Defined Responsibilities
Clear mandate defining specific tasks and responsibilities in relation to the covered IVD devices.
Key Tasks
- Verify manufacturer compliance with applicable regulations
- Keep technical documentation and EU declaration of conformity available
- Cooperate with competent authorities on request
- Immediately inform manufacturer of complaints and non-conforming products
- Terminate mandate if manufacturer acts contrary to obligations
Ready to Enter European Markets?
Get expert regulatory guidance tailored to your IVDs
Our cross-cultural team of scientists and engineers is ready to support your European market journey.