Standards Development

Scope

This PAS specifies requirements for continuous glucose monitoring (CGM) systems intended to be used alone, or in conjunction with, digitally connected medical devices for the purpose of managing diseases or medical conditions related to glycaemic control by lay persons and healthcare professionals.

In particular, requirements relate to:

a)    design verification and validation procedures for the analytical and clinical performance of CGM systems;

b)    the applicability and assessment of cybersecurity risks and threats to CGM systems; and

c)     the provision of information on CGM performance characteristics supplied by the manufacturer to CGM users.

This PAS does not:

•           provide a comprehensive evaluation of all possible factors that could affect the performance of CGM systems;

•           pertain to glucose concentration measurement for the purpose of diagnoses of a medical condition or disease relating to glycaemic control, including diabetes mellitus;

•           address the medical aspects of diabetes mellitus management;

•           apply to in vitro blood glucose monitoring devices; or

•           apply to CGM systems that do not have a medical purpose, including products intended for wellness and fitness trackers.

NOTE Although this PAS applies to CGM system safety and performance in the UK, it might be useful as a benchmark for other markets.

The PAS is intended to be used by manufacturers of CGM systems, and is expected to be of interest to organizations (e.g. regulatory authorities and conformity assessment bodies) responsible for assessing the performance of these systems.