Master IVDR Compliance and Substance Safety

To secure a CE Mark and maintain market access in the EU, in vitro diagnostic (IVD) medical devices must be proven safe and effective for their intended use. Regulation (EU) 2017/746 (IVDR) Annex I establishes rigorous general safety and performance requirements for the design and verification of IVD products. Navigating these requirements, especially for hazardous substances, is essential for a successful submission.

SAXOCON provides the specialized expertise required to plan, test, and document compliance with IVDR requirements, including:

• Material and Reagent Characterization:
  Expert selection and screening to ensure compatibility with body fluids, cells, or tissue samples.
• Hazardous Substance Evaluation:
  Assessing compliance with Regulation (EU) 1272/2008 (CLP) governing the classification and labelling of hazardous substances.
• Laboratory Oversight:
  Selecting qualified laboratories, reviewing technical protocols, and monitoring required tests to ensure data integrity.
• Toxicological Risk Assessment:
  Expert analysis of results to finalize the safety profile of your device and its components.

Why Choose SAXOCON?

Our services for IVD manufacturers give you access to:

• A Multidisciplinary Team:
  Expert toxicologists, material scientists, and supply chain professionals working in unison.
• IVDR Expertise:
  Extensive experience with state-of-the-art safety evaluations that align with the latest international standards and regional regulations.
• Exclusive Data Insights:
  Safety evaluations informed by non-disclosed information obtained from our global network of material suppliers.
• Commercial Efficiency:
  Smart, cost-effective test strategies designed to minimize delays and accelerate your time-to-market.

Delivery

SAXOCON compiles all necessary evidence into a comprehensive Biological Evaluation Report (BER). This audit-ready documentation provides the technical justification required for product approval and ensures your technical files are fully compliant with IVDR standards.