Reviewed guidance topic
Clinical and performance evidence
Umbrella category for clinical investigation/evaluation and IVD performance studies/evaluation.
Official catalogue · non-binding
Clinical and performance evidence guidance (18)
Catalogue entries are ordered as they appear in the European Commission catalogue.
MDCG 2025-5Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746June 2025⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- June 2025
Source document
- MDCG 2025-5PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-15Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMEDNovember 2024⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- November 2024
Source document
- MDCG 2024-15PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-10Clinical evaluation of orphan medical devicesJune 2024⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- June 2024
Source document
- MDCG 2024-10PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-5 MDCG 2024-5 Appendix AGuidance on the Investigator’s Brochure contentAppendix A of the MDCG 2024-5April2024April2024⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- April2024April2024
Source documents
- MDCG 2024-5PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
- MDCG 2024-5 Appendix ADOCX · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
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⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- March 2024March 2024
Source documents
- MDCG 2024-3PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
- MDCG 2024-3 Appendix ADOCX · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
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⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- December 2023
Source document
- MDCG 2023-7PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
2023/C 163/06Commission Guidance on the content and structure of the summary of the clinical investigation reportMay 2023⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- May 2023
Source document
- 2023/C 163/06HTML · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-28Substantial modification of clinical investigation under Medical Device RegulationDecember 2021⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- December 2021
Source document
- MDCG 2021-28PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
Show all 18 guidance documentsShow only the first 8
MDCG 2021-20Instructions for generating CIV-ID for MDR Clinical InvestigationsJuly 2021⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- July 2021
Source document
- MDCG 2021-20PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-8Clinical investigation application/notification documentsMay 2021⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- May 2021
Source document
- MDCG 2021-8PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-6 - rev.1Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigationDecember 2023⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- December 2023
Source document
- MDCG 2021-6 - rev.1PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-13 - Word versionClinical evaluation assessment report templateJuly 2020⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- July 2020
Source documents
- MDCG 2020-13PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
- Word versionDOCX · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
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⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- October 2022October 2022
Source documents
- MDCG 2020-10/1 rev.1PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
- MDCG 2020-10/2 rev.1XLSX · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-8Guidance on PMCF evaluation report templateApril 2020⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- April 2020
Source document
- MDCG 2020-8PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-7Guidance on PMCF plan templateApril 2020⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- April 2020
Source document
- MDCG 2020-7PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-6Guidance on sufficient clinical evidence for legacy devicesBackground note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev.4 on clinical evaluationApril 2020⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- April 2020
Source documents
- MDCG 2020-6PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
- Background notePDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-5Guidance on clinical evaluation – EquivalenceApril 2020⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- April 2020
Source document
- MDCG 2020-5PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2019-9 - rev.1Summary of safety and clinical performanceMarch 2022⌄
- Catalogue section
- Clinical investigation and evaluation, performance studies and evaluation
- Published
- March 2022
Source document
- MDCG 2019-9 - rev.1PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.