ESRS Mapping Index
European Sustainability Reporting Standards Reference
The Company operates this 2025 report as an ESRS Reference Year. To enable global stakeholders to use this report as an ESRS-aligned report, both disclosed items and reasons for non-disclosure are clearly indicated against the 12 ESRS topical standards (ESRS 1 and 2 + E1–E5 + S1–S4 + G1). This index, together with the GRI Index, forms a dual index.
1. Need for ESRS Mapping
The EU Corporate Sustainability Reporting Directive (CSRD) applies to large companies from Fiscal Year 2024 and to listed small and medium-sized enterprises from 2026. While i-SENS, Inc. is not directly subject to the CSRD, demand from global customers, EU partners, and EU investors for double-materiality-based disclosure is rapidly increasing, so the Company aligns this report as an ESRS Reference. This index consists of four tables.
· Table 1 — Mapping of 12 ESRS topical standards (which chapter of this report addresses each)
· Table 2 — Cross-mapping of GRI 2021 ↔ ESRS (linking last year's GRI Index to this year's ESRS)
· Table 3 — Non-material ESRS items and rationale (ESRS 2 BP-2 reasons for non-disclosure)
· Table 4 — Mapping of EU product regulations (IVDR · AI Act · PPWR) ↔ this report
2. Table 1.1 — General (ESRS 1 · 2)
ESRS Code | Disclosure Requirement | Location in this Report |
ESRS 1 3 | Double Materiality Principle | 02-2 Double Materiality Assessment |
ESRS 2 BP-1 | General reporting basis | 01-1 About this Report |
ESRS 2 BP-2 | Reasons for specific information non-disclosure | 01-1 About this Report + Table 3 |
ESRS 2 GOV-1 | Administrative, management and supervisory bodies | 05-1 Governance |
ESRS 2 GOV-2 | Information flow | 02-3 ESG Management + 05-5 AI Ethics |
ESRS 2 GOV-3 | ESG performance incentives | 02-3 ESG Management |
ESRS 2 GOV-4 | Due diligence statement | 04-4 Human Rights Management |
ESRS 2 GOV-5 | Risk management and internal control | 05-3 Risk Management |
ESRS 2 SBM-1 | Strategy and business model | 01-4 Business + 01-5 ESG Vision |
ESRS 2 SBM-2 | Stakeholder understanding | 02-4 Stakeholder Communication |
ESRS 2 SBM-3 | Material issue impact, risk, and opportunity | 02-2 Double Materiality Assessment |
ESRS 2 IRO-1 | IRO identification and assessment process | 02-2 Double Materiality Assessment |
ESRS 2 IRO-2 | ESRS disclosures addressed in this report | 06-3 This Index |
3. Table 1.2 — Environment (ESRS E1 ~ E5)
ESRS Code | Disclosure Requirement | Location in this Report | DMA Rating |
ESRS E1 | Climate change | 03-2 Climate Crisis and GHG (TCFD) + 06-7 TCFD Index | Comm Gap (E-02 Energy) |
E1-1 | Transition plan | 03-2 + 01-5 ESG Vision | — |
E1-2 / 3 / 4 | Policies, actions, targets | 03-2 PAT | — |
E1-5 / 6 / 7 | Energy and GHG | 03-2 + 06-1 Performance Data | — |
E1-8 / 9 | Pricing and financial impact | 03-2 + 02-2 IRO | — |
ESRS E2 | Pollution | 03-1 Environmental Management + 03-3 Resource Circulation | Monitoring |
ESRS E3 | Water and marine resources | 03-4 Water Resources Management | Monitoring |
ESRS E4 | Biodiversity and ecosystems | Non-material — see Table 3 (Biodiversity Policy 03-1) | Non-material (E-08) |
ESRS E5 | Resource use and circular economy | 03-3 Resource Circulation and EU PPWR + 03-5 Environmentally Friendly Products | Comm Gap (E-07 Chemicals) |
4. Table 1.3 — Social (ESRS S1 ~ S4)
ESRS Code | Disclosure Requirement | Location in this Report | DMA Rating |
ESRS S1 | Own workforce | 04-2 Talent Management + 04-3 Safety and Health Management | Dual S-11a, S-11b · Comm S-15 |
S1-1 / 2 / 3 | Policies, engagement, remedy | 04-2 + 04-3 + 04-4 | — |
S1-4 | Actions | 04-2 PAT + 04-3 PAT | — |
S1-5 | Targets | 04-2 PAT + 04-3 PAT | — |
S1-6 ~ S1-17 | Quantitative indicators | 06-1 Performance Data | — |
ESRS S2 | Workers in the value chain | 04-5 Supply Chain + 04-4 Human Rights Management | Blind G-33 (adjacent) |
ESRS S3 | Affected communities | 04-6 Local Community Contribution | Monitoring |
ESRS S4 | Consumers and end-users | 04-1 Patient Safety and Product Responsibility | Dual S-12, S-22, S-21, S-24 |
S4-1 | Policy | 04-1 PAT Policy | — |
S4-2 | Engagement | 04-1 + 02-4 Stakeholders | — |
S4-3 | Remedy channels | 04-1 Single Patient Rights Channel + 05-4 Information Security | — |
S4-4 | Actions | 04-1 PAT Action | — |
S4-5 | Targets and indicators | 04-1 PAT Target / Metric | — |
5. Table 1.4 — Governance (ESRS G1)
ESRS Code | Disclosure Requirement | Location in this Report | DMA Rating |
ESRS G1 | Business conduct | 05-2 Ethics Management | Dual G-27 Corruption |
G1-1 | Code of conduct and policy | 05-2 PAT Policy | - |
G1-2 | Supplier management | 04-5 Supply Chain | - |
G1-3 | Anti-corruption and internal reporting | 05-2 + UNGC P10 | - |
G1-4 | Corruption incidents | 06-1 Performance Data | - |
G1-5 | Political influence | 05-2 | - |
G1-6 | Payment practices | 04-5 Supply Chain | - |
6. Table 2 — Cross-Mapping of GRI 2021 ↔ ESRS (Summary)
This table shows how the GRI Standards 2021 index of last year's report is linked to this ESRS index. Both 1:N and N:1 mappings occur.
GRI 2021 | Topic | ESRS Mapping | Location in this Report |
GRI 2 | General Disclosures | ESRS 2 BP-1 · BP-2 · GOV · SBM | 01 · 02 · 05 |
GRI 3-1 ~ 3 | Materiality | ESRS 1 3 + IRO-1 · 2 + SBM-3 | 02-2 DMA |
GRI 205 | Anti-corruption | ESRS G1-3, G1-4 | 05-2 (Dual G-27) |
GRI 302 | Energy | ESRS E1-5 | 03-2 |
GRI 303 | Water | ESRS E3 | 03-4 |
GRI 305 | GHG emissions | ESRS E1-6, E1-7 | 03-2 + TCFD Index |
GRI 306 | Waste | ESRS E5-3, E5-4 | 03-3 |
GRI 308 · 414 | Supplier assessment | ESRS S2 + E1-2 | 04-5 |
GRI 401 · 403 · 404 · 405 | Employment, health and safety, training, diversity | ESRS S1-6 · S1-14 · S1-13 · S1-9 | 04-2 · 04-3 |
GRI 413 | Local community | ESRS S3-1 ~ S3-4 | 04-6 |
GRI 416 | Customer safety and health | ESRS S4-4 | 04-1 (Dual S-12) |
GRI 417 | Marketing and labeling | ESRS S4-4 | 04-1 Responsible Marketing |
GRI 418 | Customer privacy | ESRS S4-3 + S4 (medical information) | 04-1 + 05-4 (Dual S-21) |
7. Table 3 — Non-Material ESRS Items and Rationale (ESRS 2 BP-2)
ESRS does not require uniform disclosure of all items; items judged non-material in the Double Materiality Assessment may be specified together with the reason for non-disclosure (ESRS 2 BP-2). In the Company's 2025 DMA, the following items were judged non-material.
ESRS Code | Item | Reason for Non-Disclosure | Future |
ESRS E4 | Biodiversity and ecosystems | E-08 Impact 5.97 / Financial 6.51, placing it in the monitoring zone. Sites (Wonju, Songdo) are located in urban and industrial areas with limited direct impact. Nonetheless, a Biodiversity Policy was proactively established in 2025 and TNFD-aligned monitoring is in operation. | Re-assessment in next year's DMA |
ESRS E2-3 | Soil pollution | Soil pollution risk is limited given the nature of medical device manufacturing processes | Monitoring |
ESRS S2-3 (partial) | Child and forced labor in the value chain | Direct risk is low given a medical device supply chain centered on electronic components and plastics | To be re-examined in CSDDD response |
ESRS S3-2 (partial) | Impact on indigenous peoples | No direct exposure to impacts on indigenous peoples given the location of sites in Korea and major markets | To be re-assessed upon new overseas entry |
ESRS G1-5 | Political funding | Company policy prohibits political contributions and donations entirely | | Annual confirmation (zero disclosure) |
8. Table 4.1 — EU Product Regulation: IVDR · EUDAMED · MDR · Cybersecurity (Lex Specialis)
EU Regulation · Provision | Mandatory Content | Application Schedule | Related ESRS |
IVDR (EU) 2017/746 | Integrated regulation for the EU market placement of IVD medical devices | Class C transition December 31, 2028 | S4-4 |
IVDR Article 110(3c) | Eligibility for transition extension (QMS · NB · EUDAMED) | NB written agreement deadline May 26, 2025 | S4-4 · GOV-5 |
IVDR Annex I GSPR 17 | Cybersecurity (Lex Specialis — excluded from CRA) | From the date of application of the body | S4-3 · S4-4 |
IVDR Article 82 | Serious incident reporting (15 / 10 / 2 days) | EUDAMED Vigilance May 28, 2026 | S4-4 |
EUDAMED 4 modules | Actor · UDI · NB/Certificate · Market Surveillance | May 28, 2026 | S4-4 · GOV-5 |
EU CRA (Reg. 2024/2847) | Cybersecurity for non-medical accessory software / applications | General application December 11, 2026 | S4-3 |
MDCG 2025-6 | IVDR / MDR × CRA interplay principles | Published February 2025 | S4-3 |
IVDR / MDR amendment (EC January 2026) | GSPR 17 × CRA cross-reference | S4-3 · GOV-5 |
9. Table 4.2 — EU AI Act (Regulation (EU) 2024/1689)
AI Act Provision | Mandatory Content | Application Schedule | Related ESRS |
Article 4 | AI literacy (training of employees and HCPs) | August 2, 2026 (not subject to Omnibus) | S1-13 · G1-1 |
Article 6(1) | Conformity assessment of embedded high-risk AI in IVDR Class C/D | Original August 2, 2027 / Omnibus August 2, 2028 | S4-4 · G1-1 |
Article 43(3) | Single integrated conformity assessment for IVDR + AI Act | Guidance 2026–2027 | G1-1 · GOV-5 |
Article 5 | Prohibited AI (e.g., social scoring) | Effective February 2, 2025 | G1-1 |
Article 99 | General governance and fines | August 2, 2026 | G1-1 · G1-4 |
AI Act Omnibus | 12-month delay in application of Annex I | GOV-5 |
10. Table 4.3 — EU PPWR (Regulation (EU) 2025/40)
PPWR Provision | Mandatory Content | Application Schedule | Related ESRS |
General application of the body | Design requirements, hazardous substance restrictions, empty space ≤50%, EPR registration | August 12, 2026 (confirmed) | E5-1 · E5-2 · E5-4 |
Article 6 | Recycling / reuse design (conditional exemption for sterility of primary packaging) | From the date of application of the body (confirmed) | E5-2 · E5-3 |
Article 7 | Recycled-material content for plastics (medical-grade exemption application possible) | January 1, 2030 first / 2040 full (confirmed) | E5-4 · E5-5 |
Article 12 | Labeling standards (partial exemption in case of IVDR/MDR conflict) | August 12, 2028 mandatory (confirmed) | E5-2 |
Article 43 | EPR registration and contributions (no exemption) | August 12, 2026 general application (confirmed) | E5-6 · G1-2 |
Delegated and implementing acts | Recycling grades, recycled-content calculation, label drafts, EPR guidance | Additional publications 2026–2028 | | E5-1 · E5-4 |