| Regulation | MDR | Medical Device Regulation (MDR) 2017/745 | Link |
| Regulation | IVDR | In-Vitro Diagnostic Regulation (IVDR) 2017/746 | Link |
| Regulation | MDR/IVDR | Transitional Provisions (2023/607) – Amending MDR (transition extension/sell-off) and IVDR (sell-off) | 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) | 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) | Link |
| Guidance | Classification | Software under the MDR and IVDR (MDCG 2019-11) | 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 |
| Guidance | EMDN | FAQ on the European Medical Device Nomenclature (MDCG 2021-12) | 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 | 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 (Team Notified Body) | Link |
| Implementing Regulation | Labeling | E-Labeling under EU 2017/745 (MDR) | 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 v2) | 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) | 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 |
| 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 | 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) | Link |
| Guidance | Person Responsible for Regulatory Compliance (PRRC) | PRRC under Art. 15 of the MDR and IVDR (MDCG 2019-07 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 (MDCG 2023-3) | Link |
| Guidance | Vigilance | Adverse Event Reporting (AER): terms, terminology, and codes (IMDRF) | Link |
| Form | Vigilance | Manufacturer Incident Report (MIR) | Link |
| Form | Vigilance | Field Safety Corrective Action (FSCA) | Link |
| Form | Vigilance | Field Safety Notice (FSN) | Link |
| Form | Vigilance | Periodic Summary Report (PSR) | Link |
