Russian-language guidance on in vitro diagnostics surveillance

A Russian translation of the 2015 publication “Post-market surveillance of in vitro diagnostics” is now available. The document outlines the objectives and processes of post-market surveillance of the in vitro diagnostics (IVDs) prequalified by WHO. It describes what should be done to ensure WHO-prequalified IVDs continue to meet requirements for safety, quality and performance after they are placed on the market.

The guidance document was presented at a workshop in Minsk, Belarus, on 4–5 July 2018 to the 10 participating countries from the WHO European Region: Armenia, Azerbaijan, Georgia, Kazakhstan, Kyrgyzstan, the Russian Federation, Tajikistan, Turkmenistan, Ukraine and the Republic of Moldova.

Manufacturers, users and regulators of WHO-prequalified IVDs are encouraged to follow this guidance. It is hoped that the Russian-language document will greatly increase the number of people able to access and implement the guidance.

IVDs are medical devices and accessories used to perform tests on samples, for example, blood or urine, in order to detect infection, establish a diagnosis and prevent disease. WHO prequalifies IVDs by undertaking a comprehensive assessment through standard procedures. The products that meet all the requirements are classed as prequalified IVDs that can be bought for use by Member States.

Protecting individual and public health

Surveillance of IVDs continues once they reach the market. They are monitored to ensure safety, quality and performance, and to ensure that manufacturers can be made aware of any adverse events. If an adverse event occurs (for example, a problem with the accuracy of a blood test), manufacturers have an obligation to immediately assess risks and take action to ensure that individual and public health are protected.