IVDR Compliance
EU Regulation 2017/746 Compliance Resources

Master IVDR Compliance. Faster.

Professional templates, checklists, and expert resources to streamline your EU In Vitro Diagnostic Regulation compliance journey.

Expert-crafted templates
IVDR-aligned content
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Everything You Need for IVDR Compliance

Comprehensive resources designed for regulatory affairs professionals, quality managers, and compliance officers.

Ready-to-Use Templates

Professional document templates covering Technical Files, GSPRs, Performance Evaluation Reports, and more. Save weeks of preparation time.

Expert Content

In-depth articles and guides written by regulatory professionals with hands-on IVDR implementation experience.

Regulatory Updates

Stay informed about IVDR amendments, MDCG guidance documents, and transitional provisions affecting your compliance strategy.

Community Knowledge

Learn from real-world implementation cases and practical insights from the IVD regulatory community.

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Trusted by Regulatory Professionals

Join hundreds of compliance teams using our templates and resources.

The IVDR Technical File template saved us months of work. The structure is comprehensive and aligned perfectly with our Notified Body's expectations.

Dr. Maria Schmidt

Regulatory Affairs Director

MedTech Solutions GmbH

Finally, a resource that understands the real challenges of IVDR compliance. The GSPR checklist alone was worth the investment.

Jean-Pierre Dubois

Quality Manager

DiagnostiQ France

The Performance Evaluation templates helped us organize our clinical evidence systematically. Our NB audit went smoothly thanks to these resources.

Anna Kowalski

Compliance Officer

Nordic IVD Labs

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Free Download

IVDR Classification Checklist

Navigate the complex IVDR device classification rules with our comprehensive checklist covering Annex VIII requirements.

  • Complete classification decision tree
  • All 7 classification rules explained
  • Risk class determination guidance

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