1 Scope
This document establishes requirements for assuring quality, safety , performance and documentation of laboratory-developed tests ( LDTs ) as per their intended use for the diagnosis, prognosis, monitoring, prevention or treatment of medical conditions.
It outlines the general principles and assessment criteria by which an LDT shall be designed, developed, characterized, manufactured, validated (analytically
and clinically) and monitored for internal use by medical laboratories.
The scope includes regulatory authority approved IVD medical devices that are used in a manner differing from approved labelling or instructions for use
for that device (e.g. use of a sample type not included in the intended use , use of instruments or reagents not included in the labelling).
While this document follows a current best practice and state-of-the art approach,
it does not provide specific details on how to achieve these requirements within specific
disciplines of the medical laboratory nor specific technology platforms.
This document does not specify requirements for examination procedures developed by research or academic laboratories developing and using testing
systems for non-IVD purposes. However, the concepts presented in this document can
also be useful for these laboratories.
This document does not apply to the design, development and industrial production
of commercially used IVD medical devices .
Открыть превью (PDF)Medical laboratories. Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests