Analysis of Roszdravnadzor data and market trends confirms that in 2026, wearable Holter ECG monitors have become the absolute leader in the number of registration applications. Their share among all submitted medical device documents has exceeded 35%. Experts from Elibrium have prepared a detailed breakdown of the reasons for this success and key nuances for manufacturers.
Why Holters?
- Telemedicine Boom. After 2025, demand for remote monitoring of patients with cardiovascular diseases surged in Russia. Wearable monitors weighing up to 50 grams allow doctors to receive real-time ECG data via Bluetooth, which is especially in demand in regions with a shortage of cardiologists.
- Simplified EAEU Procedure. Since 2026, for portable devices of risk class IIa, a reduced expert review period applies — only 50 working days with a valid ISO13485 certificate. Previously, this process took up to 12 months.
- Home Use. Modern devices require no special skills — the patient can independently attach the monitor and transmit data via a mobile application. Minimal packaging requirements and the absence of complex reagents simplify logistics.
Key Recommendations from Elibrium:
- Software as a Separate Device. If your device analyzes arrhythmias or generates automatic reports, its software must be registered as an independent medical device. Without this, the simplified procedure is unavailable.
- Registration Timelines. With a properly prepared dossier, registration can be completed in 5–6 months. A practical example.
- QR Marking. Starting April 1,2026, all medical devices must have a QR code on the packaging linking to the unified EAEU registry. Ensure your device is entered into the registry before starting production.
What Will Change by 2028?
The simplified registration procedure for Holters is valid only until 2028. After that, stricter requirements for software and clinical trials are planned. Therefore, experts recommend not delaying the submission of your application.
Elibrium has already helped12 manufacturers successfully register wearable monitors. For your device, we will prepare a personalized checklist. Contact us for a consultation — leave a request on our website. The opportunities of simplified registration are limited in time!
