| Legislation | MDR | Medical Device Regulation (MDR) 2017/745 (consolidated) | Link |
| Legislation | IVDR | In-Vitro Diagnostic Regulation (IVDR) 2017/746 (consolidated) | Link |
| Legislation | MDR/IVDR | Regulation (EU) 2023/607 – Amending MDR (transition extension/sell-off) and IVDR (sell-off) | Link |
| Legislation | MDR/IVDR | Regulation (EU) 2024/1860 – Gradual roll-out of Eudamed, obligation to inform of interruption or discontinuation of supply, and transitional provisions for certain IVDs | Link |
| Legislation | MDD | Medical Devices Directive (MDD) 93/42/EEC | Link |
| Legislation | AIMDD | Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC | Link |
| Legislation | IVDD | In Vitro Diagnostic medial devices Directive (IVDD) 98/79/EC | Link |
| Guidance | MDD/AIMDD | Clinical Evaluation: A Guide for Manufacturers and Notified Bodies (MEDDEV 2.7/1 Rev. 4) | Link |
| Guidance | Clinical Evaluation | Clinical evaluation – Equivalence (MDCG 2020-5) | Link |
| Guidance | Clinical Evaluation | Summary of safety and clinical performance (MDCG 2019-9 Rev.1) | Link |
| Guidance | Clinical Evaluation | Exemptions from the requirement to perform clinical investigations per MDR Art. 61(4)-(6) (MDCG 2023-7) | Link |
| Guidance | Clinical Investigation | Clinical Investigation Plan contents & synopsis template (MDCG 2024-3) | Link |
| Guidance | Classification | Medical Devices under the MDR (MDCG 2021-24) | Link |
| Guidance | Classification | IVDs under the IVDR (MDCG 2020-16 Rev.4) | Link |
| Guidance | Classification | Guidance on qualification of in vitro diagnostic medical devices (MDCG 2024-11) | Link |
| Guidance | Classification | Software under the MDR and IVDR (MDCG 2019-11 Rev.1) | Link |
| Manual | Classification | Manual on borderline and classification for medical devices under the MDR and IVDR | Link |
| Website | Common Specifications | Common Specifications (all) | Link |
| Guidance | Custom-Made Devices | Q&A on Custom-Made Devices (MDCG 2021-3) | Link |
| Guidance | Custom-Made Devices | Personalized Medical Devices – Regulatory Pathways (IMDRF) | Link |
| Website | EMDN | EMDN database | Link |
| Resource | EMDN | EMDN Version History, 2024 (MDCG 2025-3) | Link |
| Resource | EMDN | Helpdesk | Link |
| Guidance | EMDN | Helpdesk User Manual | Link |
| Guidance | EMDN | FAQ on the European Medical Device Nomenclature (MDCG 2021-12 Rev.1) | Link |
| Guidance | EMDN | Procedure for Updates to EMDN (MDCG 2024-2 Rev.1) | Link |
| Guidance | EMDN | MedTech Europe’s ‘Practical Guide for the use of EMDN | Link |
| Website | EUDAMED | ‘Restricted’ Site (site you must use to register) | Link |
| Website | EUDAMED | Public Database | Link |
| Website | EUDAMED | ‘Playground/sandbox’ | Link |
| Website | EUDAMED | Information Center | Link |
| Guidance | EUDAMED | Actor Registration Module: User Guide | Link |
| Guidance | EUDAMED | UDI/Devices Registration Module: User Guide | Link |
| Guidance | EUDAMED | Q&A on the Gradual Rollout of EUDAMED | Link |
| Guidance | General | IMDRF Technical Documents (all) | Link |
| Guidance | General | MDCG Guidance Documents (all) | Link |
| Position Paper | General | Team Notified Body Position Papers (all) | Link |
| Position Paper | IVDR Technical Documentation | Best Practices for submission of Technical Documentation under Annex II and III of the IVDR v2 (Team Notified Body) | Link |
| Implementing Regulation | Labeling | Regulation (EU) 2021/2226 (e-Labeling under EU MDR 2017/745), as amended by Regulation (EU) 2025/1234 | Link |
| Resource | Labeling | National Language Requirements under the MDR and IVDR | Link |
| Guidance | Labeling | Guidance on Implant Cards – Device Types (MDCG 2021-11) | Link |
| Guidance | Labeling | Guidance on Implant Cards on the application of Article 18 Regulation (MDCG 2019-8 Rev.2) | Link |
| Guidance | Legacy Devices | Significant changes regarding the transitional provision under Article 120 of the MDR (MDCG 2020-3) | Link |
| Guidance | Legacy Devices | Significant changes regarding the transitional provision under Article 110(3) of the IVDR (MDCG 2022-6) | Link |
| Guidance | Legacy Devices | Application of MDR requirements to MDD/AIMDD ‘legacy devices’ (MDCG 2021-25 Rev.1) | Link |
| Guidance | Legacy Devices | Application of IVDR requirements to IVDD ‘legacy devices’ (MDCG 2022-8) | Link |
| Guidance | Legacy Devices | Q&A on the MDR transition extension (i.e., implementation of Regulation (EU) 2023/607) | Link |
| Guidance | Legacy Devices | Q&A on the IVDR transition extension (i.e., implementation of Regulation (EU) 2024/1860) | Link |
| Position Paper | MDR Technical Documentation | Best Practices for Submission of Technical Documentation under Annex II and III of the MDR (Team Notified Body) | Link |
| Position Paper | MDR Technical Documentation | Medical Device Lifetime (Team Notified Body) | Link |
| Guidance | Performance Evaluation | Q&A regarding performance studies under the IVDR (MDCG 2025-5) | Link |
| Guidance | Performance Evaluation | Performance study application/notification documents under IVDR (MDCG 2022-19) | Link |
| Guidance | Performance Evaluation | General principles of clinical evidence for IVDs (MDCG 2022-2) | Link |
| Guidance | Performance Evaluation | Summary of safety and performance template (MDCG 2022-9 Rev.1) | Link |
| Guidance | Person Responsible for Regulatory Compliance (PRRC) | PRRC under Art. 15 of the MDR and IVDR (MDCG 2019-7 Rev.1) | Link |
| Form | Post-market Monitoring | Manufacturer Information Form on Interruption or Discontinuation of Supply of devices (MDCG 2024-16) | Link |
| Guidance | Post-market Monitoring | Q&A on the Obligation to inform in case of interruption or discontinuation of supply (Rev.1) | Link |
| Guidance | Post-market Surveillance | PMCF Evaluation Report Template (MDCG 2020-8) | Link |
| Guidance | Post-market Surveillance | PMCF Plan Template (MDCG 2020-7) | Link |
| Guidance | Post-market Surveillance | Periodic Safety Update Report (PSUR) according to the MDR (MDCG 2022-21) | Link |
| Website | Standards | Harmonized Standards (all) | Link |
| Guidance | UDI | Q&A on the Unique Device Identification (UDI) system (MDCG 2022-7) | Link |
| Website | UDI | UDI Helpdesk | Link |
| Guidance | Vigilance | Guidelines on a Medical Devices Vigilance System (MEDDEV 2.12/1 Rev.8) | Link |
| Guidance | Vigilance | Q&A on Vigilance terms and concepts under the MDR & IVDR (MDCG 2023-3 Rev.2) | Link |
| Guidance | Vigilance | Adverse Event Reporting (AER): terms, terminology, and codes (IMDRF) (March 2025) | Link |
| Form | Vigilance | Manufacturer Incident Report (MIR) Form 7.2.1 (available until November 2025) | Link |
| Form | Vigilance | Manufacturer Incident Report (MIR) Form 7.3.1 (mandatory starting November 2025) | Link |
| Guidance | Vigilance | Manufacturer Incident Report Help Text (for Form 7.3.1) | Link |
| Form | Vigilance | Field Safety Corrective Action (FSCA) Form | Link |
| Form | Vigilance | Field Safety Notice (FSN) Template | Link |
| Form | Vigilance | Field Safety Notice (FSN) Customer Reply | Link |
| Form | Vigilance | Field Safety Notice (FSN) Distributor/Importer Reply | Link |
| Guidance | Vigilance | Field Safety Notice Q&A | Link |
| Form | Vigilance | Periodic Summary Report Form | Link |
| Form | Vigilance | Trend Report Form | Link |
