Regulatory NewsIVDR Transitional Provisions: Timeline and Strategy Planning
Navigate the extended IVDR transition periods with this comprehensive timeline guide and strategic planning recommendations.

Professional templates, checklists, and expert resources to streamline your EU In Vitro Diagnostic Regulation compliance journey.
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Professional document templates covering Technical Files, GSPRs, Performance Evaluation Reports, and more. Save weeks of preparation time.
In-depth articles and guides written by regulatory professionals with hands-on IVDR implementation experience.
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“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.”
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Quality Manager
DiagnostiQ France
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Anna Kowalski
Compliance Officer
Nordic IVD Labs
Navigate the complex IVDR device classification rules with our comprehensive checklist covering Annex VIII requirements.
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Regulatory NewsNavigate the extended IVDR transition periods with this comprehensive timeline guide and strategic planning recommendations.
IVDR FundamentalsNavigate the IVDR classification rules with this practical guide, including examples for common IVD device types and tips for borderline cases.
Performance EvaluationComplete guide to planning and executing performance evaluation studies under IVDR, covering scientific validity, analytical performance, and clinical performance requirements.
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