Technical Guidance Series
The Technical Guidance Series (TGS) was developed following a WHO consultation held in 2015 and attended by experts from national regulatory authorities, national reference laboratories, and WHO prequalification dossier reviewers and inspectors. The guidance series is a result of their efforts, and those of other international working groups, to provide clear information to manufacturers seeking WHO prequalification of in vitro diagnostics (IVDs).
TSG documents apply in principle to all IVDs that are eligible for WHO prequalification for use in WHO Member States. They should be read in conjunction with relevant international and national standards and guidance.
TGS 1 Standards applicable to the WHO Prequalification of in vitro diagnostic medical devices: identifies standards and guidance relating to a range of issues that are encountered in the manufacture, verification, and validation of IVDs.
TGS 2 Establishing stability of in vitro diagnostic medical devices: provides IVD manufacturers with guidance on possible approaches to determining stability and describes WHO prequalification requirements for stability testing.
- Annex to TGS 2 Establishing component stability for in vitro diagnostic medical devices: provides recommendations for establishing the stability of components for IVDs, with examples on the change from establishing stability for multi-use dropper bottles to establishing stability for single-use vials.
TGS 3 Principles of performance studies: identifies the key principles that apply when conducting and reporting the study design, results, and conclusion of analytical and clinical performance studies that support performance claims for IVDs undergoing assessment for WHO prequalification.
TGS 4 Test method validation for in vitro diagnostic medical devices: provides guidance to manufacturers on the validation of the test methods used in establishing the design, development and manufacture of an IVD.
TGS 5 Designing instructions for use for in vitro diagnostic medical devices: provides guidance to manufacturers on best practice when designing the instructions for use (IFU), which are an opportunity for the manufacturer to interact directly interact with end users and inform them about their product.
TGS 6 Panels for quality assurance and quality control of in vitro diagnostic medical devices: provides IVD manufacturers with guidance on possible approaches to preparation of validation panels for quality assurance (QA) and quality control (QC) and describes WHO prequalification requirements with respect to the QA and QC information that must be submitted for prequalification assessment.
TGS 7 Risk management for manufacturers of in vitro diagnostic medical devices: developed to help manufacturers of IVDs develop appropriate risk management within their quality management system before compiling a product dossier for submission to WHO and in preparation for site inspection as part of WHO prequalification assessment.
TGS 8 Quality control for in vitro diagnostic medical devices for WHO prequalification: developed to guide IVD manufacturers in the development of QC criteria, focusing on determining whether quality requirements for the product are being met, and specifically to identify any defects in the products produced.