You can download a DRM-free copy of this standard here.
What is PAS 2600:2025 Continuous glucose monitoring systems – Design verification and validation of performance – Specification about?
PAS 2600 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.
Who is PAS 2600:2025 Continuous glucose monitoring systems – Design verification and validation of performance – Specification for?
- Medical Device Manufacturers
- Regulatory Authorities
- Conformity assessment bodies
What does PAS 2600:2025 Continuous glucose monitoring systems – Design verification and validation of performance – Specification cover?
This PAS covers continuous glucose monitoring (CGM) systems designed to automatically measure glucose levels in bodily fluids over time. The PAS provides guidance on the design, performance and safety of CGM systems including sensors, transmitters and receivers. It also covers their use in managing glucose levels for individuals with diabetes mellitus and other conditions related to glycaemic control.
Additionally, the standard highlights the need for robust clinical data to demonstrate the accuracy and performance of CGM systems. It sets requirements for data protection, cybersecurity and system integrity, especially when systems are connected to mobile, cloud-based, or other medical devices.
Why should you use PAS 2600:2025 Continuous glucose monitoring systems – Design verification and validation of performance – Specification?
- Safety: it establishes a consistent benchmark for the performance and reliability of continuous glucose monitoring (CGM) systems, helping to reduce risks associated with inaccurate readings and ensuring safer glucose management for users.
- Consistency: it provides a unified framework similar to established medical standards such as ISO 10993 and IEC 60601, ensuring that CGM devices meet minimum safety and performance requirements across different regions.
- Regulatory alignment: it supports compliance with key regulatory frameworks, including the FDA, UK MDR, and EU MDR, offering manufacturers a clear pathway to meet approval standards and accelerate market access.
- Efficiency: it streamlines testing and validation processes for manufacturers by setting out clear performance and safety criteria, reducing duplication of effort across jurisdictions.
- Data protection: it addresses modern challenges such as cybersecurity and data privacy, ensuring the integrity and security of user health data in digitally connected devices.
- Public health impact: it enhances diabetes management outcomes by promoting more accurate and reliable CGM systems.
What has changed?
PAS 2600:2025 is a new publication.
