Standards Development

Scope

The proposed standard document specifies requirements for ensuring quality, safety and performance of laboratory-developed tests (LDT). It outlines the general principles and assessment criteria by which LDT shall be designed, developed, manufactured, validated and monitored for internal use by medical laboratories.

While the proposed standard follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within certain disciplines of medical laboratory testing.

This document does not cover requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-in-vitro-diagnostic purposes. However, the concepts presented in this document may also be useful for these institutions. The proposed standard does not apply to the design, development and industrial production of commercially used in vitro diagnostic medical devices.

Purpose

While regulatory requirements for commercially available medical devices including in vitro diagnostic medical devices (IVD) are constantly increasing all over the world, there is a controversial debate with regard to so-called “in-house” IVD or laboratory developed tests (LDT).

Although, - especially in the case of rare and emerging diseases and as the current COVID-19 pandemic has again revealed -, LDT have a central impact on patient diagnosis and treatment, there is currently no common understanding or internationally harmonised approach for essential quality, safety and performance requirements for LDT that medical laboratories could apply.

In the past, several countries such as Canada, Australia and the United States of America have developed national standards and/or regulations covering certain requirements for LDT. In the EU, the new Regulation (EU) 2017/746 (“IVDR”) includes harmonized legal requirements for IVD that are manufactured and used in the same health institution.

However, a practical and state-of-the-art interpretation of these requirements is currently not existent and in many less regulated regions and countries of the world, reliable concepts for medical laboratories using LDT are missing.

Since LDT have a highly significant impact on both individual patient care and on public health and safety, the existence of an internationally harmonized approach for best-practice requirements for LDT is understood as a key component of the quality of medical laboratory examinations and therefore of patient care and safety as a whole.

The proposed document will therefore be beneficial not only for medical laboratories, but also for related stakeholders such as regulatory authorities and/or accreditation bodies monitoring the quality and performance of these laboratories.

The proposed standard document shall therefore set requirements that represent a state-of-the-art approach for ensuring quality, safety and performance of LDT. It will outline the general principles and assessment criteria by which in-house IVDs shall be designed, developed, manufactured, validated and monitored for use by medical laboratories.