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Clinical investigations

Planning, conduct, reporting, modification, or submission of MDR clinical investigations.

Official catalogue · non-binding

Clinical investigations guidance (9)

Catalogue entries are ordered as they appear in the European Commission catalogue.

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MDCG 2024-15Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMEDNovember 2024
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
November 2024
Topics

Source document

  • MDCG 2024-15PDF · Unverified extraction previewOfficial source

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MDCG 2024-3 MDCG 2024-3 Appendix AGuidance on content of the Clinical Investigation Plan for clinical investigations of medical devicesClinical Investigation Plan Synopsis TemplateMarch 2024March 2024
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
March 2024March 2024
Topics

Source documents

  • MDCG 2024-3PDF · Unverified extraction previewOfficial source

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  • MDCG 2024-3 Appendix ADOCX · Unverified extraction previewOfficial source

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MDCG 2023-7Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access’ to data needed to justify claims of equivalenceDecember 2023
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
December 2023
Topics

Source document

  • MDCG 2023-7PDF · Unverified extraction previewOfficial source

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2023/C 163/06Commission Guidance on the content and structure of the summary of the clinical investigation reportMay 2023
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
May 2023
Topics

Source document

  • 2023/C 163/06HTML · Unverified extraction previewOfficial source

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MDCG 2021-28Substantial modification of clinical investigation under Medical Device RegulationDecember 2021
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
December 2021
Topics

Source document

  • MDCG 2021-28PDF · Unverified extraction previewOfficial source

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MDCG 2021-20Instructions for generating CIV-ID for MDR Clinical InvestigationsJuly 2021
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
July 2021
Topics

Source document

  • MDCG 2021-20PDF · Unverified extraction previewOfficial source

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MDCG 2021-8Clinical investigation application/notification documentsMay 2021
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
May 2021
Topics

Source document

  • MDCG 2021-8PDF · Unverified extraction previewOfficial source

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MDCG 2021-6 - rev.1Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigationDecember 2023
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
December 2023
Topics

Source document

  • MDCG 2021-6 - rev.1PDF · Unverified extraction previewOfficial source

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Show all 9 guidance documentsShow only the first 8
MDCG 2020-10/1 rev.1 MDCG 2020-10/2 rev.1Guidance on safety reporting in clinical investigationsAppendix: Clinical investigation summary safety report formOctober 2022October 2022
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
October 2022October 2022
Topics

Source documents

  • MDCG 2020-10/1 rev.1PDF · Unverified extraction previewOfficial source

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  • MDCG 2020-10/2 rev.1XLSX · Unverified extraction previewOfficial source

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