Patient Safety and Product Quality

At the moment a diabetic patient assesses his or her own health with a single drop of blood from a fingertip every day, the accuracy of that measurement and the safety of the device are directly linked to the patient's life. This is why i-SENS makes patient safety and product responsibility the foremost priorities of management. In the 2025 Double Materiality Assessment (DMA), "S-12 Product Defects and Recall" also recorded an Impact Materiality of 8.55 and a Financial Materiality of 9.13, ranking first in Dual Material among all 34 issues, reaffirming, as in the previous year, that this is a core area for which i-SENS, as a medical device company, must take fundamental responsibility. This chapter integrates and discloses the patient safety and product responsibility governance accumulated over 25 years and the performance achieved.

1. 2025 Key Performance

In 2025, i-SENS continued its clean record on "market recalls," the most direct indicator of patient safety. There were zero cases of market recalls due to EU MDR non-conformities, zero U.S. FDA Class I, II, or III recalls, and zero warnings or surcharges due to violations of the Ministry of Food and Drug Safety (MFDS) GMP; adverse event reports were also 0 cases, maintaining a clean status in the EU market. The Company also actively responded to customer voices: of the 42,997 customer complaints received in 2025, 42,463 were processed, achieving a processing rate of 98.8%. In terms of quality certifications, the Company maintains ISO 13485:2016, the international standard for medical device quality management systems (renewed in April 2026, valid until March 2029), and applies ISO 15197:2013, the performance standard for blood glucose monitoring systems, to all Blood Glucose Monitoring (BGM) lines.

2. Patient Safety Governance (S6-1, S6-2 / ESRS S4-4, S4-5)

Patient safety governance operates on three pillars based on 25 years of experience in the medical device industry. First, a patient safety oversight system is established under the ESG Committee of the Board of Directors, with the Co-CEO bearing direct responsibility; this satisfies the requirements of the Serious Accidents Punishment Act and EU MDR Article 14. Second, the Quality Management System (QMS) is operated globally on an integrated basis based on ISO 13485:2016, with 4 plants and 10 subsidiaries following the same procedures. Third, through external certifications and audits, the Company simultaneously meets the requirements of 7 licensing authorities, including the FDA QSR, EU MDR, MDSAP (an integrated program for 5 countries — Australia, Brazil, Canada, Japan, and the United States), MFDS GMP, NMPA, PMDA, and CDSCO.

3. Market Recalls — Performance on Managing the Top Dual Material Issue

For S-12 (Impact 8.55, Financial 9.13), the top Dual Material issue derived from the Double Materiality Assessment, i-SENS manages "0 recalls" as a core anti-KPI. During the reporting period, no market recall occurred at any of the major regulatory agencies worldwide. Specifically, for EU MDR Article 87 (Field Safety Corrective Action), U.S. FDA 21 CFR Part 806 (Class I, II, and III Recall), Article 31 (Recall and Disposal) of the Korean Medical Devices Act enforced by the MFDS, China's NMPA medical device regulations, and the quality system inspection criteria of Japan's PMDA, 0 cases have been maintained for three consecutive years from 2023 through 2025.

4. Product Accuracy and Safety Standard (ISO 15197:2013)

Blood glucose monitors are medical devices used directly by patients, and the accuracy of measurement directly affects insulin dosing, dietary control, and emergency situation judgment. All BGM and Continuous Glucose Monitoring (CGM) products of i-SENS meet the ISO 15197:2013 accuracy criteria. The requirement that, for blood glucose ranges of 100 mg/dL or higher, at least 95% of measurement results fall within ±15% of the reference value, and for ranges below 100 mg/dL, within ±15 mg/dL, is met across all shipping lots; for electromagnetic interference (EMC), the Company meets the IEC 60601-1-2 standard and provides relevant information in the instructions for use. In addition, measurement can be performed in 5 seconds with a minimum blood sample of 0.5 μL, and clinical evaluation is conducted based on the ISO 14971 risk management framework.

5. Labeling and Instructions for Use (GRI 417 · EU MDR Annex I Part III)

All products are provided with labeling and instructions for use that conform to EU MDR Annex I Part III, FDA 21 CFR Part 801, and the MFDS medical device labeling and recording regulations. Instructions for Use are provided simultaneously in Korean and English for all products, and detail manual familiarization prior to use and safety precautions. For product identification, the EU UDI, FDA UDI, and the MFDS medical device standard code (EPIS) are indicated in an integrated manner, and the expiration date of strips and recommended storage temperature and humidity conditions are specified on the label. The Company also provides information on risk and contraindications such as EMC interference, precautions for use by pregnant women and children, and drug interactions, and recommends that used lancets be disposed of in biological waste containers and provides information on disposal in accordance with local regulations.

6. Simultaneous Compliance with 7 Global Medical Device Licenses

The Company simultaneously meets the requirements of 7 global medical device licensing authorities and holds a licensing portfolio at an industry-leading level. In the United States, beginning with BGM in 2008, the Company has continued FDA 510(k) premarket notifications; in Europe, the Company completed its full transition to EU MDR in May 2024 and obtained CE certification for CareSens Air in the same year. Beyond these, the Company applies MDSAP covering Australia, Brazil, Canada, Japan and the United States; Korea's MFDS GMP; the NMPA for i-SENS Jiangsu, which handles the Chinese market; PMDA QMS based on Japanese conformity assessment; and the CDSCO certification for i-SENS BIOSENSORS INDIA.

7. Customer Complaint Handling System

In 2025, i-SENS received 42,997 customer complaints and processed 42,463 of them, recording a processing rate of 98.8%. Most of the received complaints were inquiries about usage, and the proportion of complaints directly related to product defects was at a very low level.

8. Full Transition to EU MDR (May 2024)

In May 2024, the Company completed its full transition to the EU Medical Device Regulation (MDR, Regulation EU 2017/745). The EU MDR is a regulation that has introduced strengthened requirements in 17 areas, including medical device classification, clinical evaluation, post-market surveillance (PMCF, PMS, PSUR), and UDI. i-SENS has renewed Clinical Evaluation Reports (CER) for all medical devices and continuously updates clinical data, and conducts post-market surveillance through Post-Market Clinical Follow-up (PMCF) plans and quarterly and annual Periodic Safety Update Reports (PSUR). In addition, the Company has secured traceability of distribution through EU EUDAMED registration and GS1 UDI code labeling, designates and maintains an in-house Person Responsible for Regulatory Compliance (PRRC), and uses i-SENS GmbH as its Authorized Representative (AR) within the EU.

9. AI Medical Device Safety — CGM Algorithm (Aligned with the EU AI Act)

The Continuous Glucose Monitoring (CGM) device falls under the High-Risk AI System category for medical devices under the classification of the EU AI Act (Regulation (EU) 2024/1689), which took effect in 2024. i-SENS's CareSens Air operates AI governance in compliance with this classification. The algorithm underwent clinical trials beginning in 2022 at Seoul National University Hospital and three other medical institutions, and obtained EU CE MDR certification in 2024; learning data is de-identified to remove patient identification information, and the source, accuracy, and bias are regularly inspected. The measurement-value calculation algorithm is disclosed and integrated into the instructions for use to secure Explainability, and the limitations of AI are clearly communicated, including recommendations to confirm with finger-prick blood sampling in the event of rapid blood glucose fluctuations. Accuracy continues to be monitored after market launch, and malfunctions are reported in accordance with EU MDR Article 87. Detailed policies are integrated and disclosed in the "AI Ethics and Responsibility" chapter.