{"id":12426,"date":"2019-10-02T12:35:37","date_gmt":"2019-10-02T10:35:37","guid":{"rendered":"https:\/\/eudamed.eu\/?page_id=12426"},"modified":"2026-04-15T12:59:06","modified_gmt":"2026-04-15T10:59:06","slug":"european_commission_mdr_eudamed_updates","status":"publish","type":"page","link":"https:\/\/eudamed.com\/index.php\/european_commission_mdr_eudamed_updates\/","title":{"rendered":"European Commission (EC), MDCG, and EUDAMED Updates"},"content":{"rendered":"

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European Commission MDR and IVDR EUDAMED Updates<\/h3>\n

<\/span><\/p>\n

Vigilance – MIR<\/a> | 2025<\/a> | 2024<\/a> | 2023<\/a> | 2022<\/a> | 2021<\/a> | 2020<\/a> | 2019<\/a><\/p>\n

Join our LinkedIn group<\/a> to receive the latest updates.<\/h4>\n

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EUDAMED<\/strong><\/h3>\n

EUDAMED Timelines<\/strong> View<\/a> EUDAMED UDI Device will be mandatory on the 28th May 2026.<\/p>\n

MDCG Publications<\/h3>\n

2026<\/h3>\n

Top<\/a> | Vigilance – MIR<\/a> | 2026<\/a> | 2025<\/a> | 2024<\/a> | 2023<\/a> | 2022<\/a> | 2021<\/a> | 2020<\/a> | 2019<\/a><\/span>
\nMDCG 2025-8 Rev. 1 <\/strong>Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
\nMarch 2026 Proposal Download<\/a> | Download<\/a><\/p>\n

2025<\/h3>\n

European Commission <\/strong>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 .
\nDecember 2025 Proposal Download<\/a> | Annex Download<\/a><\/p>\n

MDCG 2025-9 <\/strong>Guidance on Breakthrough Devices (BtX) under Regulations 2017\/745 & 2017\/746.
\nDecember 2025 Download<\/a><\/p>\n

MDCG 2025-8 <\/strong>Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
\nNovember 2025 Download<\/a><\/p>\n

2025 <\/strong> Manual on borderline and classification for medical devices under Regulation (EU) 2017\/745 on medical devices and Regulation (EU) 122017\/746 on in vitro diagnostic medical devices, Version 4.
\nSeptember 2025 Download<\/a>
\nBackground note: Download<\/a><\/p>\n

MDCG 2024-14 Rev. 1 <\/strong> Guidance on the implementation of the Master UDI-DI solution for contact lenses.
\nAugust 2025 Download<\/a><\/p>\n

2025-7<\/strong> MDCG Position Paper: Timelines of the implementation of \u2018Master UDI-DI\u2019 to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
\nJuly 2025 Download<\/a><\/p>\n

2025-6<\/strong> FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)
\nJune 2025 Download<\/a><\/p>\n

2025-5<\/strong> Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017\/746
\nJune 2025 Download<\/a><\/p>\n

MDCG 2025-4 <\/strong> Guidance on the safe making available of medical device software (MDSW) apps on online platforms
\nJune 2025 Download<\/a><\/p>\n

MDCG 2019-11 Rev 1<\/strong> Qualification and classification of software – Regulation (EU) 2017\/745 and Regulation (EU) 2017\/746
\nJune 2025 Download<\/a><\/p>\n

MDCG 2019-6 Rev 5<\/strong> Questions and answers: Requirements relating to notified bodies
\nFebruary 2025 Download<\/a><\/p>\n

MDCG 2025-1 <\/strong>EMDN Ad hoc procedure form.
\nJanuary 2025 Download<\/a><\/p>\n

MDCG 2025-2 <\/strong>Summary of EMDN 2024 Submissions and outcome of annual revision.
\nJanuary 2025 Download<\/a><\/p>\n

MDCG 2025-3 <\/strong>EMDN Version History (Excel).
\nJanuary 2025 Download<\/a><\/p>\n

MDCG 2021-12 Rev.1 <\/strong>FAQ on the European Medical Device Nomenclature (EMDN).
\nJanuary 2025 Download<\/a><\/p>\n

MMDCG 2024-2 Rev.1\u00a0 <\/strong>Procedures for the updates of the EMDN
\nJanuary 2025 Download<\/a><\/p>\n

MDCG 2023-3 Rev. 3 <\/strong>Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017\/745 on medical devices and Regulation (EU) 2017\/746.
\nJanuary 2025 Download<\/a><\/p>\n

2024<\/h3>\n

Top<\/a> | Vigilance – MIR<\/a> | 2026<\/a> | 2025<\/a> | 2024<\/a> | 2023<\/a> | 2022<\/a> | 2021<\/a> | 2020<\/a> | 2019<\/a><\/span>
\nMDCG 2022-3 Rev.1 <\/strong>Verification of manufactured class D IVDs by notified bodies.
\n<\/strong>December 2024 Download<\/a><\/p>\n

MDCG 2019-13 Rev.1 <\/strong>Guidance on sampling of devices for the assessment of the technical documentation
\n<\/strong>December 2024 Download<\/a><\/p>\n

MDCG 2024-16 <\/strong>Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices.
\n<\/strong>November 2024 Download Form<\/a> \u00a0 Download Annex<\/a><\/p>\n

MDCG 2024-15<\/strong> Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED.
\nNovember 2024 Download<\/a><\/p>\n

MDCG 2024-11<\/strong> Q&A on practical aspects related to the gradual roll-out of Eudamed for MDR and IVDR, the impacts and obligations in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.
\nNovember 2024 Download<\/a><\/p>\n

MDCG 2023-3 rev.1<\/strong> Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017\/745 under Regulation (EU) 2017\/746.
\nNovember 2024 Download<\/a><\/p>\n

Q&A Obligation<\/strong> to inform in case of interruption or discontinuation of supply.
\nOctober 2024 Download<\/a><\/p>\n

MDCG 2024-13<\/strong> Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices.
\nOctober 2024 Download<\/a><\/p>\n

MDCG 2022-05 Rev.\u00a0<\/strong>1\u00a0<\/strong>Guidance<\/span>\u00a0on borderline between medical devices and medicinal products under Regulation (EU) 2017\/745 on medical devices.
\nOctober 2024 Download<\/a><\/p>\n

MDCG 2021-25 Rev. 1<\/strong> Regulation (EU) 2017\/745 – application of MDR requirements to \u2018legacy devices\u2019 and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90\/385\/EEC or 93\/42\/EEC
\nOctober 2024 Download<\/a><\/p>\n

MDCG 2024-11<\/strong> Guidance on qualification of in vitro diagnostic medical devices.
\nOctober 2024 Download<\/a><\/p>\n

MDCG\u00a0<\/strong>2024-12 <\/strong>Corrective<\/span>\u00a0and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams.
\nOctober 2024 Download<\/a><\/p>\n

Annex I: Template CAPA plan and assessment thereon Download<\/a><\/p>\n

Annex II: Template JAT review of the CAPA and the DA’s opinion Download<\/a><\/p>\n

Extension of the IVDR transitional periods<\/strong> Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR
\nJuly 2024 Download<\/a><\/p>\n

The EU Regulations on medical devices and in vitro diagnostic medical devices<\/strong>
\nInformation session for international regulators and stakeholders.
\nJuly 2024 Download<\/a><\/p>\n

MDCG 2020-16 Rev.2 Rev.3<\/strong> Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017\/746
\nJuly 2024 Download<\/a><\/p>\n

MDCG 2021-5 Rev. 1<\/strong> Guidance on standardisation for medical devices Revision 1
\nJuly 2024 Download<\/a><\/p>\n

MDCG 2024-10<\/strong> Clinical evaluation of orphan medical devices.
\nJune 2024 Download<\/a><\/p>\n

MDCG 2022-13 Rev.1<\/strong> Designation, re-assessment and notification of conformity assessment bodies and notified bodies.
\nJune 2024 Download<\/a><\/p>\n

MDCG 2024-1-5<\/strong> Guidance on the vigilance system for CE-marked devices. Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence.
\nJune 2024 Download<\/a><\/p>\n

MDCG 2024-9<\/strong> Preliminary re-assessment review (PRAR) form template (IVDR)
\nMay 2024 Download<\/a><\/p>\n

MDCG 2024-8<\/strong> Preliminary re-assessment review (PRAR) form template (MDR)
\nMay 2024 Download<\/a><\/p>\n

MDCG 2024-7<\/strong> Preliminary assessment review (PAR) form template (IVDR)
\nMay 2024 Download<\/a><\/p>\n

MDCG 2024-6<\/strong> Preliminary assessment review (PAR) form template (MDR)
\nMay 2024 Download<\/a><\/p>\n

MDCG 2024-5<\/strong> guidance on content of the Investigator\u2019s Brochure for clinical investigations of medical devices
\nApril 2024 Download<\/a><\/p>\n

MDCG 2024-4 <\/strong>Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices.
\nApril 2024 Download<\/a> An accompanying appendix is available here<\/a><\/p>\n

MDCG 2022-9 \/ Rev.1 <\/strong>Summary of safety and performance Template.
\nApril 2024 Download<\/a><\/p>\n

MDCG 2024-3 <\/strong>Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices.
\nMarch 2024 Download<\/a> An accompanying appendix is available here<\/a><\/p>\n

MDCG 2024-2 <\/strong>Procedures for the updates of the European Medical Device Nomenclature.
\nFebruary 2024 Download<\/a><\/p>\n

MDCG 2024-1 <\/strong>Guidance on the vigilance system for CE-marked devices.
\nJanuary 2024 Download<\/a><\/p>\n

MDCG 2024-1-1<\/strong> DSVG 01 on Cardiac ablation
\nJanuary 2024 Download<\/a><\/p>\n

MDCG 2024-1-2<\/strong> Guidance on the vigilance system for CE-marked devices.
\nJanuary 2024 Download<\/a><\/p>\n

MDCG 2024-1-3 <\/strong>Guidance on the vigilance system for CE-marked devices.
\nJanuary 2024 Download<\/a><\/p>\n

MDCG 2024-1-4 <\/strong>Guidance on the vigilance system for CE-marked devices.
\nJanuary 2024 Download<\/a><\/p>\n

2023<\/h3>\n

Top<\/a> | Vigilance – MIR<\/a> | 2026<\/a> | 2025<\/a> | 2024<\/a> | 2023<\/a> | 2022<\/a> | 2021<\/a> | 2020<\/a> | 2019<\/a><\/span>
\nMDCG 2023-7 <\/strong>Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on \u2018sufficient levels of access\u2019 to data needed to justify claims of equivalence.
\nDecember 2023 Download<\/a><\/p>\n

MDCG 2021-27 <\/strong>Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017\/745 and Regulation (EU) 2017\/746.
\nDecember 2023 Download<\/a><\/p>\n

MDCG 2019-07 <\/strong>Rev.1 Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a \u2018person responsible for regulatory compliance\u2019 (PRRC).
\nDecember 2023 Download<\/a><\/p>\n

MDCG 2023-6 <\/strong>Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies.
\nDecember 2023 Download<\/a><\/p>\n

MDCG 2023-5 <\/strong>Guidance on qualification and classification of Annex XVI products A guide for manufacturers and notified bodies
\nDecember 2023 Download<\/a><\/p>\n

MDCG 2021-6 Rev. 1 <\/strong>Regulation (EU) 2017\/745 \u2013 Questions & Answers regarding clinical investigation.
\nDecember 2023 Download<\/a><\/p>\n

MDCG 2022-11 Rev.1 <\/strong>MDCG Position Paper – Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements.
\nNovember 2023 Download<\/a><\/p>\n

MDCG 2023-4 <\/strong>Medical Device Software (MDSW) \u2013 Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components
\nOctober 2023 Download<\/a><\/p>\n

UDI for contact lenses <\/strong>Commission Delegated Regulation (EU) 2023\/2197 of 10 July 2023 amending Regulation (EU) 2017\/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses
\nOctober 2023 Download<\/a><\/p>\n

Q&A <\/strong>on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR
\nSeptember 2023 Download<\/a><\/p>\n

Extension Q&A Rev.1 <\/strong> on practical aspects related to the implementation of Regulation (EU) 2023\/607 amending Regulations (EU) 2017\/745 and (EU) 2017\/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
\nJuly 2023 Download<\/a><\/p>\n

MDCG 2020-3 Rev.1 <\/strong>Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
\nMay 2023 Download<\/a><\/p>\n

2023\/C 163\/06 <\/strong>Commission Guidance on the content and structure of the summary of the clinical investigation report (Text with EEA relevance) 2023\/C 163\/06
\nMay 2023 Download<\/a><\/p>\n

Extension Q&A <\/strong> on practical aspects related to the implementation of Regulation (EU) 2023\/607 amending Regulations (EU) 2017\/745 and (EU) 2017\/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
\nMarch 2023 Download<\/a><\/p>\n

MDCG 2023-3 <\/strong>Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017\/745 on medical devices
\nFebruary 2023 Download<\/a><\/p>\n

MDCG 2020-16 Rev. 2 <\/strong>Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017\/746
\nFebruary 2023 Download<\/a><\/p>\n

MDCG 2023-01<\/strong> Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017\/745 and Regulation (EU) 2017\/746
\nJanuary 2023 Download<\/a><\/p>\n

MDCG 2023-02<\/strong> List of Standard Fees
\nJanuary 2023 Download<\/a><\/p>\n

2022<\/h3>\n

Top<\/a> | Vigilance – MIR<\/a> | 2026<\/a> | 2025<\/a> | 2024<\/a> | 2023<\/a> | 2022<\/a> | 2021<\/a> | 2020<\/a> | 2019<\/a><\/span>
\nMDCG 2022-04 Rev 1 – <\/strong>Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD
\nDecember 2022 Download<\/a><\/p>\n

MDCG 2022-21 – <\/strong>GUIDANCE ON PERIODIC SAFETY UPDATE REPORT (PSUR) ACCORDING TO REGULATION (EU) 2017\/745 (MDR)
\nDecember 2022 Download<\/a><\/p>\n

MDCG 2022-20 – <\/strong>Substantial modification of performance study under Regulation (EU) 2017\/746
\nDecember 2022 Download<\/a><\/p>\n

MDCG 2022-19 – <\/strong>Performance study application\/notification documents under Regulation (EU) 2017\/746
\nDecember 2022 Download<\/a><\/p>\n

MDCG 2022-18 – <\/strong>MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
\nDecember 2022 Download<\/a><\/p>\n

MDCG 2022-17 – <\/strong>MDCG position paper on \u2018hybrid audits\u2019
\nDecember 2022 Download<\/a><\/strong><\/p>\n

MDCG 2022-16 –<\/strong>Guidance on Authorised Representatives Regulation (EU) 2017\/745 on medical devices (MDR) and Regulation (EU) 2017\/746 on in vitro diagnostic medical devices (IVDR)
\nOctober 2022 Download<\/a><\/p>\n

MDCG UPDATE MDCG 2020-10\/1 Rev 1<\/strong> Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017\/745
\nOctober 2022 Download<\/a><\/p>\n

MDCG UPDATE MDCG 2020-10\/2 Rev 1<\/strong> Excel template
\nOctober 2022 Download<\/a><\/p>\n

MDCG Publication 2019-6 Rev 4<\/strong>\u00a0Questions and answers: Requirements relating to notified bodies
\nOctober 2022 Download<\/a><\/p>\n

MDCG 2022-15<\/strong>\u00a0Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD
\nSeptember 2022 Download<\/a><\/p>\n

MDCG 2021-22 Rev.1<\/strong> (September 2022) Clarification on \u201cfirst certification for that type of device\u201d and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017\/746
\nSeptember 2022 Download<\/a><\/p>\n

MDCG 2022-14<\/strong> MDCG Position Paper Transition to the MDR and IVDR Notified body capacity and availability of medical
\ndevices and IVDs
\nAugust 2022 Download<\/a><\/p>\n

MDCG 2022-13<\/strong> Designation, re-assessment and notification of conformity assessment bodies and notified bodies
\nAugust 2022 Download<\/a><\/p>\n

MDCG 2022-12<\/strong> Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017\/746 on in vitro diagnostic medical devices)
\nJuly 2022 Download<\/a><\/p>\n

MDCG 2022-11<\/strong> MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements.
\nJune 2022 Download<\/a><\/p>\n

MDCG 2022-10<\/strong> Q&A on the interface between Regulation (EU) 536\/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017\/746 on in vitro diagnostic medical devices (IVDR).
\nMay 2022 Download<\/a><\/p>\n

MDCG 2022-9<\/strong> Summary of safety and performance template.
\nMay 2022 Download<\/a><\/p>\n

MDCG 2022-8<\/strong> Regulation (EU) 2017\/746 – application of IVDR requirements to \u2018legacy devices\u2019 and to devices placed on the market prior to 26 May 2022 in accordance with directive 98\/79\/EC
\nMay 2022 Download<\/a><\/p>\n

MDCG 2022-7<\/strong> Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017\/745 and Regulation (EU) 2017\/746
\nMay 2022 Download<\/a><\/p>\n

MDCG 2022-6<\/strong> Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
\nMay 2022 Download<\/a><\/p>\n

MDCG 2022-5<\/strong> Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017\/745 on medical devices
\nApril 2022 Download<\/a><\/p>\n

MDCG 2019-9 Rev.1<\/strong> Summary of safety and clinical performance. A guide for manufacturers and notified bodies.
\nMarch 2022 Download<\/a><\/p>\n

MDCG 2022-4<\/strong> Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD
\nFebruary 2022 Download<\/a><\/p>\n

MDCG 2022-3<\/strong>\u00a0Verification of manufactured class D IVDs by notified bodies
\nFebruary 2022 Download<\/a><\/p>\n

MDCG 2021-21 Rev.1<\/strong> Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
\nFebruary 2022 Download<\/a><\/p>\n

MDCG 2022-2 <\/strong>Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)
\nJanuary 2022 Download<\/a><\/p>\n

MDCG 2022-1 <\/strong>Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices
\nJanuary 2022 Download<\/a><\/p>\n

MDCG 2020-16 Rev.1 <\/strong>Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017\/746
\nJanuary 2022 Download<\/a><\/p>\n

2021<\/h3>\n

Top<\/a> | Vigilance – MIR<\/a> | 2026<\/a> | 2025<\/a> | 2024<\/a> | 2023<\/a> | 2022<\/a> | 2021<\/a> | 2020<\/a> | 2019<\/a><\/span>
\nMDCG 2021-28<\/strong> MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation.
\nDecember 2021 Download<\/a><\/p>\n

MDCG 2021-27<\/strong>\u00a0 MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017\/745 and Regulation (EU) 2017\/746.
\nDecember 2021 Download<\/a><\/p>\n

MDCG 2021-26<\/strong> Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017\/745 and Regulation (EU) 2017\/746.
\nOctober 2021 Download<\/a><\/p>\n

MDCG 2021-25<\/strong> Regulation (EU) 2017\/745 – application of MDR requirements to \u2018legacy devices\u2019 and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90\/385\/EEC or 93\/42\/EEC. October 2021 Download<\/a><\/p>\n

MDCG 2021-24<\/strong> Guidance on classification of medical devices.
\nOctober 2021 Download<\/a><\/p>\n

MDCG 2021-23<\/strong> Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017\/745 and Regulation (EU) 2017\/746
\nAugust 2021 Download<\/a><\/p>\n

MDCG 2021-22<\/strong> Clarification on \u201cfirst certification for that type of device\u201d and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017\/746
\nAugust 2021 Download<\/a><\/p>\n

MDCG 2021-21<\/strong> Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices.
\nAugust 2021 Download<\/a><\/p>\n

MDCG 2021-20<\/strong> Instructions for generating CIV-ID for MDR Clinical Investigations
\nJuly 2021 Download<\/a><\/p>\n

MDCG 2021-19<\/strong> Guidance note integration of the UDI within an organisation\u2019s quality management system.
\nJuly 2021 Download<\/a><\/p>\n

MDCG 2021-18<\/strong> Applied-for scope of designation and notification of a conformity assessment body \u2013 Regulation (EU) 2017\/746 (IVDR)
\nJuly 2021 Download<\/a><\/p>\n

MDCG 2021-17<\/strong>
\nMDCG 2021-17 Applied-for scope of designation and notification of a conformity assessment body \u2013 Regulation (EU) 2017\/745 (MDR)
\nJuly 2021 Download<\/a><\/p>\n

MDCG 2021-16<\/strong> Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)
\nJuly 2021 Download<\/a><\/p>\n

MDCG 2021-15<\/strong> Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR)
\nJuly 2021 Download<\/a><\/p>\n

MDCG 2021-14<\/strong> Explanatory note on IVDR codes
\nJuly 2021 Download<\/a><\/p>\n

MDCG 2021-13<\/strong> Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR
\nJune 2021 Download<\/a><\/p>\n

MDCG 2021-12<\/strong> FAQ on the European Medical Device Nomenclature (EMDN)
\nJune 2021 Download<\/a><\/p>\n

MDCG 2021-11<\/strong> Guidance on Implant Card \u2013 Device types.
\nJune 2021 Download<\/a><\/p>\n

MDCG 2021-10<\/strong> The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices.
\nJune 2021 Download<\/a><\/p>\n

MDCG 2021-9<\/strong> MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers.
\nMay 2021 Download<\/a><\/p>\n

MDCG 2021-8<\/strong> Clinical investigation application\/notification documents. Also covers what to do in the absence of EUDAMED.
\nMay 2021 Download<\/a><\/p>\n

MDCG 2021-7<\/strong> Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices
\nMay 2021 Download<\/a><\/p>\n

MDCG 2018-1 Rev.4 <\/strong>Guidance on BASIC UDI-DI and changes to UDI-DI
\n<\/strong>April 2021 Download<\/a><\/p>\n

MDCG 2021-6<\/strong> Regulation (EU) 2017\/745 \u2013 Questions & Answers regarding clinical investigation
\nApril 2021 Download<\/a><\/p>\n

MDCG 2021-5<\/strong> Guidance on standardisation for medical devices
\nApril 2021 Download<\/a><\/p>\n

MDCG 2021-4<\/strong> Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017\/746
\nApril 2021 Download<\/a><\/p>\n

MDCG 2021<\/strong>\u00a0Is your software a medical device?
\nMarch 2021 Download<\/a><\/p>\n

MDCG 2021-3<\/strong> Questions and Answers on Custom-Made Devices
\nMarch 2021 Download<\/a><\/p>\n

MDCG 2021-2<\/strong> Guidance on the state of the art of COVID-19 rapid antibody tests
\nMarch 2021 Download<\/a><\/p>\n

MDCG 2021-1<\/strong> Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
\nMarch 2021 Download<\/a><\/p>\n

2020<\/h3>\n

Top<\/a> | Vigilance – MIR<\/a> | 2026<\/a> | 2025<\/a> | 2024<\/a> | 2023<\/a> | 2022<\/a> | 2021<\/a> | 2020<\/a> | 2019<\/a><\/span>
\nMDCG 2020-18<\/strong> MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
\nDecember 2020 Download<\/a><\/p>\n

MDCG 2020-17<\/strong> Questions and Answers related to MDCG 2020-4:
\n\u201cGuidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions\u201d
\nNovember 2020 Download<\/a><\/p>\n

MDCG 2020-16<\/strong> Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017\/746
\nNovember 2020 Download<\/a><\/p>\n

MDCG 2020-15<\/strong> MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States
\nAugust 2020 Download<\/a><\/p>\n

MDCG 2020-14<\/strong> Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)\/In Vitro Diagnostic medical devices Regulation (IVDR)<\/p>\n

August 2020 Download<\/a><\/p>\n

MDCG 2019-15 rev.1<\/strong> Guidance notes for manufacturers of Class I medical devices<\/p>\n

July 2020 Download<\/a><\/p>\n

MDCG 2020-2 rev.1<\/strong> Class I Transitional provisions under Article 120 (3 and 4) \u2013 (MDR)<\/p>\n

July 2020 Download<\/a><\/p>\n

MDCG 2019-16 rev.1<\/strong> Guidance on Cybersecurity for medical devices<\/p>\n

July 2020 Download<\/a><\/p>\n

MDCG 2019-10 rev.1<\/strong> Application of transitional provisions concerning the validity of certificates issued in accordance to Directives 90\/385\/EEC and 93\/42\/EEC<\/p>\n

July 2020 Download<\/a><\/p>\n

MDCG 2020-13<\/strong> Clinical evaluation assessment report template<\/p>\n

July 2020 Download<\/a><\/p>\n

MDCG 2018-3<\/strong> Rev.1 Guidance on UDI for systems and procedure packs<\/p>\n

June 2020 Download<\/a><\/p>\n

MDCG 2020-12<\/strong> Transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product […] as well as on devices manufactured using TSE susceptible animal tissues<\/p>\n

June 2020 Download<\/a><\/p>\n

MDCG 2020-11<\/strong> Guidance on the renewal of designation and monitoring of notified bodies under Directives 90\/385\/EEC and 93\/42\/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020\/666 amending Commission Implementing Regulation<\/p>\n

May 2020 Download<\/a><\/p>\n

MDCG 2020-10\/1<\/strong> Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017\/745<\/p>\n

May 2020 Download<\/a><\/p>\n

MDCG 2020-10\/2<\/strong> Clinical Investigation Summary Safety Report Form<\/p>\n

May 2020 Download<\/a><\/p>\n

MDCG 2020-9<\/strong> Regulatory Requirements for Ventilators and Related Accessories<\/p>\n

May 2020 Download<\/a><\/p>\n

MDCG 2020-8<\/strong> Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies<\/p>\n

April 2020 Download<\/a><\/p>\n

MDCG 2020-7<\/strong> Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies<\/p>\n

April 2020 Download<\/a><\/p>\n

MDCG 2020-6<\/strong> Regulation (EU) 2017\/745: Clinical evidence needed for medical devices previously CE marked under Directives 93\/42\/EEC or 90\/385\/EEC. A guide for manufacturers and notified bodies<\/p>\n

April 2020 Download<\/a><\/p>\n

MDCG 2020-5<\/strong> Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies<\/p>\n

April 2020 Download<\/a><\/p>\n

MDCG 2020-4<\/strong> Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions<\/p>\n

April 2020 Download<\/a><\/p>\n

MDCG 2020-3<\/strong> Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD<\/p>\n

March 2020 Download<\/a><\/p>\n

MDCG 2020-2<\/strong> Class I Transitional provisions under Article 120 (3 and 4) \u2013 (MDR)<\/p>\n

March 2020 Download<\/a><\/p>\n

MDCG 2020-1<\/strong> Guidance on Clinical Evaluation (MDR) \/ Performance Evaluation (IVDR) of Medical Device Software
\nMarch 2020 Download<\/a><\/p>\n

MDCG <\/strong>Joint Implementation\/preparedness plan on the new Medical Devices Regulation 2017\/745 (MDR)<\/p>\n

March 2020 Download<\/a><\/p>\n

MDCG 2019-8 v2<\/strong> Guidance document – Implant Card relating to the application of Article 18 Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices<\/p>\n

March 2020\u00a0 Download<\/a><\/p>\n

MDCG 2018-1 v3<\/strong> Guidance on BASIC UDI-DI and changes to UDI-DI<\/p>\n

March 2020 Download<\/a><\/p>\n

2019<\/h3>\n

Top<\/a> | Vigilance – MIR<\/a> | 2025<\/a> | 2024<\/a> | 2023<\/a> | 2022<\/a> | 2021<\/a> | 2020<\/a> | 2019<\/a><\/span>
\nMDCG 2019-9<\/strong> Summary of safety and clinical performance (SSCP) A guide for manufacturers and notified bodies (August 2019)<\/p>\n

September 2019 SSCP Guide<\/a><\/p>\n

MDCG 2019-10<\/strong> Certificates MDD & MDR. Application of transitional provisions concerning the validity of certificates issued in accordance to Directives 90\/385\/EEC and 93\/42\/EEC<\/p>\n

October 2019\u00a0 Download<\/a><\/p>\n

MDCG 2019-11<\/strong> Guidance on Qualification and Classification of Software in Regulation (EU) 2017\/745 \u2013 MDR and Regulation (EU) 2017\/746 \u2013 IVDR<\/p>\n

October 2019 Download<\/a><\/p>\n

MDCG 2019-12<\/strong> Designating authority’s final assessment form: Key Information (EN)
\nOctober 2019 Download<\/a><\/p>\n

MDCG 2019-13<\/strong> Guidance on sampling of MDR Class IIa \/ Class IIb and IVDR Class B \/ Class C devices for the assessment of the technical documentation(EN)
\nDecember 2019 Download<\/a><\/p>\n

MDCG 2019-14<\/strong> Explanatory note on MDR codes (EN)
\nDecember 2019 Download<\/a><\/p>\n

MDCG 2019-15<\/strong> Guidance notes for manufacturers of Class I medical devices (EN)
\nDecember 2019 Download<\/a><\/p>\n

MDCG 2019-16<\/strong> Guidance on Cybersecurity for medical devices (EN)
\nJanuary 2020 Download<\/a>
\nJune 2020 Download<\/a><\/p>\n

Manufacturer Incident Report (MIR Form) – Vigilance reporting<\/h3>\n

Top<\/a> | Vigilance – MIR<\/a> | 2025<\/a> | 2024<\/a> | 2023<\/a> | 2022<\/a> | 2021<\/a> | 2020<\/a> | 2019<\/a><\/span>
\n18th July 2025<\/strong><\/p>\n

The European Commission has released the new\u00a0Manufacturer Incident Report (MIR 7.3.1)<\/strong>\u00a0form. This updated\u00a0MIR PDF format\u00a0<\/b>will become\u00a0mandatory as of November 2025<\/strong> for all manufacturers of medical devices under MDR.<\/p>\n