Back to all posts

In-Vitro Diagnostic Consultancy: Navigating IVDR Compliance

Dr. Michael Johnson
Dr. Michael Johnson
6 min read
Modern laboratory setup with in-vitro diagnostic testing equipment

The In Vitro Diagnostic Regulation (IVDR) has transformed the regulatory landscape for IVD manufacturers. Understanding and implementing these requirements demands expert guidance and comprehensive regulatory knowledge.

The IVDR Challenge

The transition to IVDR brings significant changes:

  • New risk-based classification system

  • Enhanced requirements for clinical evidence

  • Stricter oversight of high-risk devices

  • More detailed technical documentation

  • Increased post-market surveillance

Key Areas of Support

Professional IVD consultancy services are crucial for:

  1. Device Classification

  • Determining risk class under IVDR

  • Understanding specific requirements

  • Planning compliance strategy

  1. Performance Evaluation

  • Scientific validity studies

  • Analytical performance assessment

  • Clinical performance evidence

  • Post-market follow-up planning

  1. Quality Management

  • ISO 13485 implementation

  • Risk management systems

  • Technical documentation

  • Post-market surveillance

Expert Guidance at Advena Medical

At Advena Medical, we provide comprehensive IVDR consultancy services:

  • Strategic regulatory planning

  • Classification support

  • Performance evaluation guidance

  • Technical documentation review

  • Post-market surveillance planning

  • Notified Body liaison

Getting Started

Ready to ensure your IVD devices meet all IVDR requirements? Visit our IVD consultancy services page to learn how we can support your compliance journey.