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Towards global in vitro diagnostic standards, Part I
1Powers Consulting Services, Pittsford, New York, USA. powers@frontiernet.net
Insights
Global harmonized standards for in vitro diagnostic products (IVD) are nearing completion. This report details the international standardization process and offers industry strategies for effective engagement.
Area of Science:
- Medical Device Regulation
- International Standards Development
Background:
- Global harmonization of in vitro diagnostic products (IVD) standards is progressing.
- Key ISO Technical Committee meetings are scheduled for finalization.
- Six specific standards are essential for the IVD Directive.
Purpose of the Study:
- To provide an overview of the international standardization process for IVDs.
- To offer actionable insights for industry engagement in standardization.
Main Methods:
- Analysis of the current status of global IVD standards development.
- Review of the ISO Technical Committee's progress and upcoming milestones.
Main Results:
- The first global harmonized IVD standards are approaching finalization.
- A significant portion of these standards are mandated for the IVD Directive.
Conclusions:
- Industry collaboration is crucial for optimizing the effectiveness of IVD standardization.
- Understanding the standardization process enables proactive industry participation.
Abstract:
The first global harmonized standards for in vitro diagnostic products (IVD) are nearing completion. The ISO Technical Committee overseeing this work will meet in June 2000 to prepare for the final vote. Six of these standards are mandated for the IVD Directive. This two-part report on the current status of these standards provides an insight into the international standardization process and suggests ways that industry can make it work more effectively.
