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Regulations	Guidance Documents	Live Resources	Standards	Templates
Decision (EU) 2025/2371 Dir. 80/181/EEC DMA EMDN Codes EU IVDR language requirements EU language requirements per country EU Member State national clinical investigation rules EU national reprocessing rules Guidance 2023/C 163/06 IMDRF AET MDR 2.0 MDR amendment proposal 2025-12-16 MIR v7.3.1 Reg (EU) 2017/745  Reg (EU) 2017/746  Reg (EU) 2024/1689 Reg (EU) 2024/1689  Reg (EU) 2016/679 Reg (EU) 2017/2185 Reg (EU) 2020/1207 Reg (EU) 2021/2226 Reg (EU) 2022/1107 Reg (EU) 2022/2346 Reg (EU) 2022/2347 Reg (EU) 2022/944 Reg (EU) 2022/945 Reg (EU) 2023/2713 Reg (EU) 2024/1860 Reg (EU) 2024/2847 Reg (EU) 2025/117 Reg (EU) 2026/977 REGULATION (EU) (MDR 2.0)	EMA FAQ marketing authorisation EMA LLM Regulatory EU FAQ EUDAMED EU FAQ Interruption EU FAQ sell off periods EU FAQ Transition Annex XVI EU FAQ transition IVDR EU Language Requirements EU Manual on borderline and classification IMDRF Software Risks MDCG 2018-1 MDCG 2018-3 MDCG 2018-4 MDCG 2018-5 MDCG 2018-6 MDCG 2018-7 MDCG 2018-8 MDCG 2019-1 MDCG 2019-11 MDCG 2019-13 MDCG 2019-14 MDCG 2019-15 MDCG 2019-16 MDCG 2019-2 MDCG 2019-3 MDCG 2019-5 MDCG 2019-7 MDCG 2019-8 MDCG 2019-9 MDCG 2020-1 MDCG 2020-10/1 MDCG 2020-10/2 MDCG 2020-12 MDCG 2020-13 MDCG 2020-14 MDCG 2020-16 MDCG 2020-2 MDCG 2020-3 MDCG 2020-5 MDCG 2020-6 MDCG 2020-7 MDCG 2020-8 MDCG 2021-11 MDCG 2021-12 MDCG 2021-13 MDCG 2021-14 MDCG 2021-19 MDCG 2021-20 MDCG 2021-22 MDCG 2021-23 MDCG 2021-24 MDCG 2021-25 MDCG 2021-26 MDCG 2021-27 MDCG 2021-28 MDCG 2021-3 MDCG 2021-4 MDCG 2021-5 MDCG 2021-6 MDCG 2021-8 MDCG 2021-9 MDCG 2022-10 MDCG 2022-15 MDCG 2022-16 MDCG 2022-18 MDCG 2022-19 MDCG 2022-2 MDCG 2022-20 MDCG 2022-21 MDCG 2022-3 MDCG 2022-4 MDCG 2022-5 MDCG 2022-6 MDCG 2022-7 MDCG 2022-8 MDCG 2022-9 MDCG 2023-1 MDCG 2023-2 MDCG 2023-3 MDCG 2023-4 MDCG 2023-5 MDCG 2023-6 MDCG 2023-7 MDCG 2024-1 MDCG 2024-1-1 MDCG 2024-1-2 MDCG 2024-1-3 MDCG 2024-1-4 MDCG 2024-1-5 MDCG 2024-10 MDCG 2024-11 MDCG 2024-13 MDCG 2024-14 MDCG 2024-15 MDCG 2024-16 MDCG 2024-3 MDCG 2024-4 MDCG 2024-5 MDCG 2025-10 MDCG 2025-4 MDCG 2025-5 MDCG 2025-6 MDCG 2025-7 MDCG 2025-8 MDCG 2025-9 MDCG 2026-4 MEDDEV 2.7/1 revision 4 SCHEER Phtalates Team-NB Changes Companion Team-NB Changes to companion diagnostic devices Team-NB CoC Team-NB IVDR Technical Documentation Team-NB MDR/IVDR revision Team-NB position Team-NB position Team-NB position Team-NB position Team-NB position IVDR Certification Process	ANSM – Vigilance BfArM – Vigilance CENELEC CLC JTC 13 FDA – Vigilance GOV UK – Vigilance HEALTH CANADA – Vigilance HPRA – Vigilance IEC JTC 1 SC 27 ISO JTC1 SC 27 IVDR harmonised standards list List NBs Fees IVDR List NBs IVDR MDR harmonised standards list NB list/fees MDR TGA – Vigilance EU : Medical Devices – In Vitro Diagnostics- Latest updates EU : Notified bodies notifications for Regulation (EU) 2017/746 Team NB : News Team NB : Documents	EN ISO 10993-1:2025 EN ISO 10993-10 EN ISO 10993-11 EN ISO 10993-12 EN ISO 10993-15 EN ISO 10993-16 EN ISO 10993-17 EN ISO 10993-18 EN ISO 10993-2 EN ISO 10993-23 EN ISO 10993-3 EN ISO 10993-4 EN ISO 10993-5 EN ISO 14630 IEC 62304+A1 IEC 62366-1 IEC 63521 IEC 81001-5-1 IEC 82304-1 IEC/TR 62366-2 ISO 10993-6 ISO 11137-1 ISO 13485 ISO 13485 guidance ISO 14155:2026 ISO 14971 ISO 15223-1 ISO 17511 ISO 17664-1 ISO 18113-1:2022 ISO 18113-2:2022 ISO 18113-3:2022 ISO 18113-4:2022 ISO 18113-5:2022 ISO 20417:2026 ISO 20916:2019 ISO 23640 ISO 24971-2 ISO 27001 ISO 31000 ISO/DIS 18969:2026 ISO/IEC 23894 ISO/TR 20416 ISO/TR 24971 ISO/TR 80002-2 XP S99-223	Document • Risk Analysis (RA) Document • Action Tracking File • Risk Management File • Instructions for Use Provided in Electronic Format (e-IFU) File • Technical Documentation Table of Contents (TD) File • IMDRF Regulatory Submission Requirements • Labelling Requirements • Information Supplied (IFU) Requirements • Electrical Safety (60601-1) General Safety and Performance Requirements (Annex I) Quality Manual Plan • Design and Development Plan • Software Development Plan • Biological Evaluation Plan • Clinical Evaluation Plan • Risk Management Plan • Usability Engineering (UE) Plan • Post-Market Clinical Follow-up (PMCF) Plan • Post-Market Surveillance (PMS) Plan • Software Testing (STP) Procedure • Risk Analysis and Benefit-Risk Assessment (B/R) Procedure • Risk-Based Approach Procedure • Audits Procedure • Design and Development Procedure • Software Life Cycle (IEC 62304) Procedure • Biological Evaluation (10993) Procedure • Clinical Evaluation Procedure • Cybersecurity Management Procedure • Purchasing Management Procedure • Management of Regulatory Communications and Registrations Procedure • Document Control Procedure • Management of Monitoring and Measuring Equipment Procedure • Customer Requirements Management Procedure • Management of Standards and Regulatory Requirements Procedure • Change Management Procedure • Human Resources Management Procedure • Risk Management Procedure • Identification and Traceability Procedure • Infrastructure and Work Environment Procedure • Usability Engineering (UE, IEC 62366-1) Procedure • Marketing and Commercial Contact with Customers Procedure • Measurement, Analysis and Improvement Procedure • Nonconformities and Corrective and Preventive Actions (NC, CAPA) Procedure • Production and Service Provision Procedure • Literature Search for Clinical Evaluation Procedure • Management Reviews Procedure • Electrical Safety (60601-1) Procedure • After-Sales Service Procedure • Post-Market Clinical Follow-up (PMCF) Procedure • Post-Market Surveillance (PMS) Procedure • Transition to the Medical Device Regulation Procedure • Production Process Validation Procedure • Validation of Software Used by the Company Procedure • Vigilance Report • Biological Evaluation Report • Clinical Evaluation Report • Usability Engineering Evaluations (UE) Report • Periodic Safety Update Report (PSUR) Report • Post-Market Clinical Follow-up (PMCF) Report • Post-Market Surveillance (PMS) Report • Software Testing Reviews • Design and Development Reviews • Risk Management Reviews • Software Life-Cycle Management Reviews • Usability Engineering (UE) Specification • Software Architecture (SAS) Specification • Device Specification • Software Requirements (SRS) Specification • Software Configuration File Specification • Software Units (SUS) Nonconformity and Corrective and Preventive Action Tracking (NC, CAPA)

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