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Illustration of an IVD Essential Requirements Checklist showing the transition from the IVDD Essential Requirements to the IVDR General Safety and Performance Requirements (GSPRs) for in vitro diagnostic medical devices.

IVD Essential Requirements Checklist: Transitioning to IVDR GSPRs

Blog, CE Marking, Client Questions, EU Regulations /

The shift from the In Vitro Diagnostic Directive (IVDD 98/79/EC) to the In Vitro Diagnostic Regulation (IVDR EU 2017/746) represents a fundamental overhaul of how technical files are structured. Under the legacy Directive, manufacturers relied on an Essential Requirements Checklist to demonstrate safety and performance. Under the IVDR, this has been completely replaced by the General Safety and Performance Requirements (GSPRs) found in Annex I.

If you are updating a legacy device technical file or migrating a quality management system, you cannot simply copy and paste your old compliance arguments. The GSPRs require a much higher degree of clinical evidence, lifecycle risk tracking, and technical specificity.

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ISO 9001 QMS

The Benefits of ISO 9001 Quality Management System

Blog, Standards /

A robust Quality Management System (QMS) isn’t just an administrative requirement—it is a strategic blueprint for scaling your operations and reducing risk. Whether you are establishing a foundational framework under ISO 9001 or navigating the specialized, compliance-heavy requirements of medical device sectors, understanding how a QMS drives efficiency is critical. Explore the 10 core business benefits of implementing a world-class quality framework and the step-by-step path to achieving accredited certification

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