The time required to obtain a CE certificate directly depends on the medical device class: the higher the risk, the stricter the requirements and the more complex and time-consuming the certification process.
Continuous glucose monitoring (CGM) systems are classified as high risk devices (class III according to EU MDR).
On average, certification of such devices (implantable stents, orthopedic implants, CGM systems) takes from 12 to 18 months or more.
The main factors affecting the timing:
• Documentation readiness: The more complete and high-quality the prepared package of documents is, the less time it will take to finalize it based on the comments of the authorized body.
• Complexity of the device: CGM is a multi-component system, where each element requires careful testing.
• Workload of authorized bodies: Mass transition to MDR causes queues and may increase the processing time for applications up to 18–24 months.
Our Certification Roadmap is a realistic, structured, and mature schedule for high-risk devices. It meets industry standards and, in some areas, even surpasses them thanks to parallel work in several areas.
Our goal is to complete CGM system certification as accurately and correctly as possible. Because the health of millions of future users is at stake.
