1 · Product Information
Required Product Name
GlucoTrack Pro — Continuous Glucose Monitoring System
Model / Type
GT-Pro 3.0 (Sensor + Transmitter + Receiver)
CN / TARIC / HS Codes
9027 80 99 — instruments for measuring physiological parameters
Required Product Description
Wearable continuous glucose monitoring (CGM) system consisting of:
— Subcutaneous sensor (14-day wear, water-resistant IP28)
— Wireless transmitter (Bluetooth 5.0 LE, 10 m range)
— Receiver/reader app (iOS & Android)
Glucose readings every 5 minutes. Alarm thresholds configurable. No fingerstick calibration required. Operates in range 2.2–27.8 mmol/L (40–500 mg/dL). CE Class IIb under MDR Annex IX.
Required Intended Use
For use by adults (18+) with diabetes mellitus (Type 1 and Type 2) who require continuous monitoring of interstitial glucose levels. Intended for home and clinical use under physician supervision. Not intended as a replacement for laboratory glucose tests in acute situations.
2 · Regulatory Basis
Required Applicable Directive(s)
MDR — Regulation (EU) 2017/745
RED — 2014/53/EU (radio transmitter)
Additional Standards
EN ISO 15223-1
IEC 62133-2 (battery safety)
EN 62368-1
ISO 15197:2013
3 · Qualification & Planning
Required Product Category
Medical Device (Class IIb)
Required Project Stage
Pre-production — pilot batch complete, clinical validation study finalised
Required Documentation Readiness
Ready — Technical File complete, Clinical Evaluation Report (CER) v2.1 available, Risk Management File per ISO 14971
Recommended Desired Timeline
Standard (within 6 months) — product launch planned for Q2 2026
Recommended Target EU Markets
GermanyFranceNetherlandsPolandAustria
Recommended QMS Status
ISO 13485:2016 certified (certificate No. QMS-2024-4412, valid until 2027)
Recommended Test Reports Available
EMC ✓Safety ✓Biocompatibility ✓Clinical ✓Software ✓
4 · Manufacturer & Supply Chain
Recommended Manufacturer Name
MedSens Technologies Ltd, 12 Innovation Park, Dublin, Ireland
Manufacturing Countries
Ireland (assembly)Germany (sensors)
5 · Digital / Cyber / AI
Has Software / Firmware
Yes — embedded firmware (transmitter, sensor ASIC) + companion mobile app classified as medical device software (MDSW)
Connectivity
Bluetooth 5.0 LECloud sync (optional)
AI Functionality
Trend prediction algorithm (SaMD — Software as Medical Device, Class IIa); covered in CER and PMCF plan
6 · Purpose of Request
Required Purpose
Conformity Assessment (MDR Annex IX)
7 · Preferred Notified Body Countries
GermanyNetherlandsIreland
8 · Additional Comments
We are currently transitioning from an MDD certificate held with BSI (UK). We require the NB to recognise existing clinical data from our MDD Technical File where applicable. Availability of an MDR-notified body with specific CGM experience is essential. We are open to a pre-submission meeting before formal application.