Describing the purpose of a health product
A practical way to describe product purpose, users and functions before discussing evidence or market requirements.
Read the resourcesectors
Diagnostics and testing technologies
Diagnostic and testing products depend on the relationship between a sample or signal, a measurement and the interpretation of a result. That relationship must be understood in the intended setting of use.
Product scope
This sector includes in vitro diagnostic tests, self-testing products, instruments and associated testing systems within the Association's scope. Laboratory and near-patient settings may involve different users, workflows and controls.
Performance and use
Discussions of performance should identify the specimen or input, the condition or parameter assessed, the comparison method and the intended users. A result obtained with one sample type, instrument configuration or population may not answer the question for another.
Areas of work
- Analytical and clinical questions relevant to the intended purpose.
- Reagents, consumables, instruments and software as a working system.
- Quality control, traceability and changes in manufacturing.
- Clear result presentation and instructions for intended users.
- Policy and access questions specific to tests and diagnostic technologies.
Resources
Technical material identifies its product scope and intended readers. Association discussion does not determine whether an individual test is authorised for a market or suitable for a particular person's care.
Reading a testing performance report in context
A structured set of questions for understanding what a testing report does and does not establish.
Read the resourceContribute technical experience
Manufacturers and relevant specialists can put forward a shared technical question, indicating the testing context and the type of output that would help the sector.