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In Vitro Diagnostic Regulation Compliance

Navigate the IVDR Landscape With Confidence

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The In Vitro Diagnostic Regulation (IVDR) introduces a stricter regulatory framework, reshaping market access for in vitro diagnostic (IVD) manufacturers in Europe. With 80% of IVDs now requiring notified body review, compliance has become more complex and time-sensitive.

Achieve IVDR compliance seamlessly. Whether launching a new device or adapting to the new regulations, our team of experts will guide you through every step—from classification and technical documentation to notified body engagement and market approval.

Let us help you bring your IVD to market with confidence. 

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How We Help Clients Meet IVDR Requirements

  • Product classification, strategy, target product profile, and roadmap development
  • Regulatory interactions
  • Gap analysis (e.g., IVD Medical Devices Directive vs. IVDR or United States vs. European Union, among others)
  • Performance data analysis and guidance on data generation strategies such as clinical trials and post-market performance follow-up
  • Technical documentation compilation and update
  • Global regulatory intelligence
  • Notified bodies selection, interactions management, and liaison during revision
  • Lifecycle maintenance including establishment of post-market surveillance requirements
  • Quality management system implementation, audit and maintenance

Why Partner With Us for Your IVDR Compliance?

Ensure your IVDs, both new and existing, meet IVDR requirements on time. Recent transition extensions mean existing CE-marked devices must comply by May 2027, with some legacy devices extended up to 2029. For new products, compliance is critical from day one. Don’t risk delays—partner with our expert team for seamless compliance and a competitive edge:

  • 100+ Food and Drug Administration, European Union Member State agencies, Notified Bodies and European Medicines Agency direct interaction and submission experience
  • In-house team of experts covering all types of medical devices, including IVDs, software devices, combination products and companion diagnostics
  • Tailored services adapted to the product characteristics, stage of regulatory compliance, and IVDR requirements
  • Knowledge of and expertise in regulations in different markets (United States, European Union, Asia-Pacific, United Kingdom, Switzerland)
  • A holistic approach to client needs thanks to our integrated team, including biometrics, clinical, market access, strategic consulting, and patient engagement experts
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