Official updates, guidance documents and publications from the European Commission and Medical Device Coordination Group (MDCG) relating to EUDAMED, MDR and IVDR.
Critical compliance milestones under MDR and IVDR.
EUDAMED Opens
EUDAMED portal launched for voluntary registration. Actor Registration module went live.
MDR Entered Full Application
EU MDR 2017/745 became fully applicable after a one-year extension from the original May 2021 date.
EUDAMED UDI Module Live
UDI/Device Registration module opened for voluntary submissions.
Class IIb MDR Deadline
MDR deadline for highest-risk Class III and implantable Class IIb devices.
IVDR Fully Applicable
IVDR 2017/746 became fully applicable following transition period extensions.
EUDAMED Mandatory
EUDAMED becomes the mandatory submission system for UDI/Device Registration under MDR and IVDR. The legacy PDF MIR form is retired.
Remaining MDR Transitions
Final deadline for remaining legacy MDR device transitions under extended transition provisions.
The latest official publications, guidance and updates from the European Commission and MDCG.
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EUDAMED Timelines — View Roadmap PDF — EUDAMED UDI Device will be mandatory on 28 May 2026.
MDCG 2025-8 Rev. 1 Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
Proposal Download | Download
European Commission Proposed amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices.
Proposal Download | Annex Download
MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746.
Download
MDCG 2025-8 Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
2025 Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 and Regulation (EU) 2017/746, Version 4.
Download | Background Note
MDCG 2024-14 Rev. 1 Guidance on the implementation of the Master UDI-DI solution for contact lenses.
MDCG 2025-7 Position Paper: Timelines of the implementation of Master UDI-DI to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
MDCG 2025-6 FAQ on Interplay between the MDR & IVDR and the Artificial Intelligence Act (AIA).
MDCG 2025-5 Questions & Answers regarding performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746.
MDCG 2025-4 Guidance on the safe making available of medical device software (MDSW) apps on online platforms.
MDCG 2019-11 Rev 1 Qualification and classification of software — Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
MDCG 2019-6 Rev 5 Questions and answers: Requirements relating to notified bodies.
MDCG 2025-1 EMDN Ad hoc procedure form.
MDCG 2025-2 Summary of EMDN 2024 Submissions and outcome of annual revision.
MDCG 2025-3 EMDN Version History (Excel).
MDCG 2021-12 Rev.1 FAQ on the European Medical Device Nomenclature (EMDN).
MDCG 2024-2 Rev.1 Procedures for the updates of the EMDN.
MDCG 2023-3 Rev. 3 Questions and Answers on vigilance terms and concepts.
MDCG 2022-3 Rev.1 Verification of manufactured class D IVDs by notified bodies.
MDCG 2019-13 Rev.1 Guidance on sampling of devices for the assessment of the technical documentation.
MDCG 2024-16 Manufacturer Information Form on Interruption or Discontinuation of Supply.
Download Form | Download Annex
MDCG 2024-15 Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED.
MDCG 2024-11 Q&A on practical aspects related to the gradual roll-out of EUDAMED, impacts and obligations in case of interruption or discontinuation of supply, and transitional provisions for certain IVDs.
Q&A Obligation to inform in case of interruption or discontinuation of supply.
MDCG 2024-13 Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices.
MDCG 2022-05 Rev. 1 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745.
MDCG 2021-25 Rev. 1 Application of MDR requirements to legacy devices and to devices placed on the market prior to 26 May 2021.
MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices.
MDCG 2024-12 Corrective and preventive action (CAPA) plan assessment guidance and templates.
Download | Annex I | Annex II
Extension of the IVDR transitional periods Q&A on practical aspects related to the implementation of the extended transitional period.
The EU Regulations on medical devices and IVDs — Information session for international regulators and stakeholders.
MDCG 2020-16 Rev.2/Rev.3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.
MDCG 2021-5 Rev. 1 Guidance on standardisation for medical devices.
MDCG 2024-10 Clinical evaluation of orphan medical devices.
MDCG 2022-13 Rev.1 Designation, re-assessment and notification of conformity assessment bodies and notified bodies.
MDCG 2024-1-5 Guidance on the vigilance system for CE-marked devices — Urogynaecological Surgical Mesh Implants.
MDCG 2024-9 Preliminary re-assessment review (PRAR) form template (IVDR). Download
MDCG 2024-8 Preliminary re-assessment review (PRAR) form template (MDR). Download
MDCG 2024-7 Preliminary assessment review (PAR) form template (IVDR). Download
MDCG 2024-6 Preliminary assessment review (PAR) form template (MDR). Download
MDCG 2024-5 Guidance on content of the Investigator's Brochure for clinical investigations of medical devices.
MDCG 2024-4 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices.
Download | Appendix
MDCG 2022-9 / Rev.1 Summary of safety and performance template.
MDCG 2024-3 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices.
Download | Appendix A
MDCG 2024-2 Procedures for the updates of the European Medical Device Nomenclature.
MDCG 2024-1 Guidance on the vigilance system for CE-marked devices. Download
MDCG 2024-1-1 DSVG 01 on Cardiac ablation. Download
MDCG 2024-1-2 Download
MDCG 2024-1-3 Download
MDCG 2024-1-4 Download
MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR.
MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
MDCG 2019-07 Rev.1 Guidance on Article 15 — Person Responsible for Regulatory Compliance (PRRC).
MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products.
MDCG 2023-5 Guidance on qualification and classification of Annex XVI products.
MDCG 2021-6 Rev. 1 Regulation (EU) 2017/745 — Questions & Answers regarding clinical investigation.
MDCG 2022-11 Rev.1 MDCG Position Paper — Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements.
MDCG 2023-4 Medical Device Software (MDSW) — Hardware combinations guidance.
UDI for contact lenses Commission Delegated Regulation (EU) 2023/2197 — UDI assignment for contact lenses.
Q&A on transitional provisions for Annex XVI products without an intended medical purpose.
Extension Q&A Rev.1 on practical aspects related to the implementation of Regulation (EU) 2023/607 — transitional provisions for certain medical devices.
MDCG 2020-3 Rev.1 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR.
2023/C 163/06 Commission Guidance on the content and structure of the summary of the clinical investigation report.
Extension Q&A on practical aspects related to Regulation (EU) 2023/607 — transitional provisions.
MDCG 2023-3 Questions and Answers on vigilance terms and concepts.
MDCG 2020-16 Rev. 2 Guidance on Classification Rules for IVDs under Regulation (EU) 2017/746.
MDCG 2023-01 Guidance on the health institution exemption under Article 5(5). Download
MDCG 2023-02 List of Standard Fees. Download
MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) under MDR. Download
MDCG 2022-20 Substantial modification of performance study under IVDR. Download
MDCG 2022-19 Performance study application/notification documents under IVDR. Download
MDCG 2022-18 Position Paper on Article 97 MDR for legacy devices. Download
MDCG 2022-17 Position Paper on hybrid audits. Download
MDCG 2022-04 Rev 1 Guidance on appropriate surveillance — Article 120 MDR. Download
MDCG 2022-16 Guidance on Authorised Representatives under MDR and IVDR. Download
MDCG 2020-10/1 Rev 1 Safety reporting in clinical investigations under MDR. Download
MDCG 2020-10/2 Rev 1 Excel template. Download
MDCG 2019-6 Rev 4 Questions and answers — Requirements for notified bodies. Download
MDCG 2022-15 Guidance on appropriate surveillance — Article 110 IVDR transitional provisions. Download
MDCG 2021-22 Rev.1 Clarification on "first certification for that type of device" for IVDR. Download
MDCG 2022-14 Position Paper — MDR/IVDR Notified body capacity and availability. Download
MDCG 2022-13 Designation, re-assessment and notification of conformity assessment bodies. Download
MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional (IVDR). Download
MDCG 2022-10 Q&A on the interface between CTR and IVDR. Download
MDCG 2022-9 Summary of safety and performance template. Download
MDCG 2022-8 Application of IVDR requirements to legacy devices. Download
MDCG 2022-7 Questions and Answers on the UDI system under MDR and IVDR. Download
MDCG 2022-6 Guidance on significant changes — Article 110(3) IVDR transitional provision. Download
MDCG 2022-5 Guidance on borderline between medical devices and medicinal products. Download
MDCG 2019-9 Rev.1 Summary of safety and clinical performance (SSCP) guide. Download
MDCG 2022-4 Guidance on appropriate surveillance — Article 120 MDR. Download
MDCG 2022-3 Verification of manufactured class D IVDs by notified bodies. Download
MDCG 2021-21 Rev.1 Guidance on performance evaluation of SARS-CoV-2 IVDs. Download
MDCG 2022-2 Guidance on general principles of clinical evidence for IVDs. Download
MDCG 2022-1 Notice to third country manufacturers of SARS-CoV-2 IVDs. Download
MDCG 2020-16 Rev.1 Guidance on Classification Rules for IVDs under IVDR. Download
MDCG 2021-28 Substantial modification of clinical investigation under MDR. Download
MDCG 2021-27 Q&A on Articles 13 & 14 of MDR and IVDR. Download
MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16. Download
MDCG 2021-25 Application of MDR requirements to legacy devices. Download
MDCG 2021-24 Guidance on classification of medical devices. Download
MDCG 2021-23 Guidance for notified bodies on certification activities under Article 16(4). Download
MDCG 2021-22 Clarification on "first certification for that type of device" — IVDR. Download
MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 IVDs. Download
MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations. Download
MDCG 2021-19 Guidance on UDI integration within QMS. Download
MDCG 2021-18 Applied-for scope of designation — IVDR. Download
MDCG 2021-17 Applied-for scope of designation — MDR. Download
MDCG 2021-13 Q&A on EUDAMED registration obligations for actors other than manufacturers. Download
MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN). Download
MDCG 2021-11 Guidance on Implant Card — Device types. Download
MDCG 2021-9 Position Paper on UDI requirements for contact lenses and spectacle frames. Download
MDCG 2021-8 Clinical investigation application/notification documents. Download
MDCG 2018-1 Rev.4 Guidance on BASIC UDI-DI and changes to UDI-DI. Download
MDCG 2021-6 Q&A regarding clinical investigation. Download
MDCG 2021-5 Guidance on standardisation for medical devices. Download
MDCG 2021-3 Questions and Answers on Custom-Made Devices. Download
MDCG 2021-1 Guidance on harmonised administrative practices until EUDAMED is fully functional. Download
MDCG 2020-18 Position Paper on UDI assignment for spectacle lenses & ready readers. Download
MDCG 2020-16 Guidance on Classification Rules for IVDs under IVDR. Download
MDCG 2020-15 Position Paper on EUDAMED actor registration and SRN. Download
MDCG 2020-14 Guidance for notified bodies on MDSAP audit reports. Download
MDCG 2019-15 rev.1 Guidance notes for manufacturers of Class I medical devices. Download
MDCG 2019-16 rev.1 Guidance on Cybersecurity for medical devices. Download
MDCG 2020-13 Clinical evaluation assessment report template. Download
MDCG 2020-12 Transitional provisions for consultations on devices incorporating medicinal products. Download
MDCG 2020-10/1 Safety reporting in clinical investigations under MDR. Download
MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories. Download
MDCG 2020-8 PMCF Evaluation Report Template. Download
MDCG 2020-7 PMCF Plan Template. Download
MDCG 2020-6 Clinical evidence for devices previously CE marked under Directives. Download
MDCG 2020-5 Clinical Evaluation — Equivalence guide. Download
MDCG 2020-3 Guidance on significant changes — Article 120 MDR. Download
MDCG 2020-1 Guidance on Clinical Evaluation / Performance Evaluation of Medical Device Software. Download
MDCG 2019-13 Guidance on sampling of MDR/IVDR devices for technical documentation assessment. Download
MDCG 2019-14 Explanatory note on MDR codes. Download
MDCG 2019-15 Guidance notes for manufacturers of Class I medical devices. Download
MDCG 2019-9 Summary of safety and clinical performance (SSCP) guide. Download
MDCG 2019-10 Certificates MDD & MDR — Application of transitional provisions. Download
MDCG 2019-11 Qualification and Classification of Software under MDR/IVDR. Download
MDCG 2019-12 Designating authority final assessment form. Download
The European Commission has released Manufacturer Incident Report (MIR 7.3.1). This updated MIR PDF format became mandatory as of November 2025 for all manufacturers of medical devices under MDR.
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