№ lp_1_2_55856
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File size: 191 KB
This document provides guidance on the design, protocol, and conduct of clinical performance studies for IVD medical devices to ensure compliance with safety and performance principles.
Year:
2012
Region / City:
Global
Topic:
Clinical Performance Studies for IVD Medical Devices
Document Type:
Guidance Document
Organization / Institution:
Global Harmonization Task Force (GHTF)
Author:
Kazunari Asanuma, GHTF Chair
Target Audience:
Manufacturers of IVD medical devices, Regulatory Authorities, Conformity Assessment Bodies
Period of Validity:
Ongoing (may apply to both pre-market and post-market studies)
Approval Date:
November 2nd, 2012
Date of Revisions:
Not specified
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Document code:
GHTF/SG1/N071:2012
Revision of:
GHTF/SG1/N29:2005
Year:
2012
Date:
May 16, 2012
Organization:
Global Harmonization Task Force
Authoring group:
Study Group 1 of the Global Harmonization Task Force
Document type:
Guidance document
Subject area:
Medical device regulation
Geographical scope:
International
Regulatory status:
Non-binding guidance
Intended audience:
Regulatory authorities, conformity assessment bodies, regulated industry
Supersedes:
Definition of the Term “Medical Device”, 2005
Copyright holder:
Global Harmonization Task Force
Year:
2021
Region / city:
International
Subject:
In Vitro Diagnostic (IVD) Medical Devices Classification
Document type:
Guidance document
Author:
IMDRF IVD Working Group
Target audience:
Regulatory Authorities, Conformity Assessment Bodies, Industry
Period of validity:
Not specified
Approval date:
21 January 2021
Amendment date:
Not specified
Copyright holder:
International Medical Device Regulators Forum
Copyright year:
2021
Note:
Year
Topic:
Clinical trials, IVD device validation
Document type:
Clinical trial documentation
Target audience:
Regulatory bodies, clinical trial staff, manufacturers
Year:
2024
Region / city:
Switzerland
Subject:
Clinical performance study for IVD devices
Document type:
Template
Organization:
swissethics
Author:
swissethics
Target audience:
Researchers, Sponsors, Ethics Committees
Period of validity:
Ongoing
Approval date:
27.06.2022
Modification date:
16.09.2024
Date of changes:
24.06.2025
Year:
2018
Region / City:
International
Topic:
Medical devices, IVD medical devices, safety, performance
Document Type:
Guideline
Organization / Institution:
International Medical Device Regulators Forum
Author:
IMDRF Good Regulatory Review Practices Group
Target Audience:
Regulatory Authorities, Conformity Assessment Bodies, manufacturers, industry stakeholders
Effective Period:
Not specified
Approval Date:
31 October 2018
Amendment Date:
Not specified
Organization:
International Medical Device Regulators Forum
Authoring Group:
IMDRF Good Regulatory Review Practices
Document type:
Guidance document
Status:
Proposed document
Identifier:
IMDRF GRRP WG (PD1)/N52
Date:
12 July 2018
Scope:
General content and format of labeling for medical devices and IVD medical devices
Applies to:
Medical devices and in vitro diagnostic medical devices
Intended audience:
Regulatory Authorities, Conformity Assessment Bodies, industry, users and relevant third parties
Supersedes:
GHTF/SG1/N70:2011 “Label and Instructions for Use”
Related principles:
IMDRF Essential Principles of Safety and Performance
Source type:
International regulatory guidance
Year:
2021
Region / City:
USA
Theme:
Medical diagnostics
Document type:
Technical datasheet
Organization:
ZEUS Scientific
Author:
ZEUS Scientific
Target audience:
Healthcare professionals, laboratory technicians
Period of validity:
Not specified
Approval date:
Not specified
Date of modifications:
Not specified
Context description:
A technical datasheet describing the components, precautions, and procedural instructions for the ZEUS IFA EBV-VCA IgM Test System for detecting EBV-VCA IgM antibodies in human sera.
Year:
2025
Organization:
World Health Organization
Department:
Regulation and Prequalification, Health Systems Division
Document type:
Expression of Interest Form
Identifier:
WHO/MHP/RPQ/PQT/2025.6
Licence:
CC BY-NC-SA 3.0 IGO
Effective date:
January 2026
Intended audience:
Legal manufacturers of in vitro diagnostic products
Submission method:
Electronic, as searchable PDF
Year:
2017
Region / city:
EU
Topic:
In vitro diagnostic medical devices, Performance studies
Document type:
Checklist
Organization:
European Union
Author:
Unknown
Target audience:
Manufacturers of in vitro diagnostic medical devices, clinical investigators, regulatory bodies
Effective period:
Ongoing
Approval date:
Unknown
Date of changes:
Unknown
Document code:
GHTF/SG1/N071:2012
Revision of:
GHTF/SG1/N29:2005
Year:
2012
Date:
May 16, 2012
Organization:
Global Harmonization Task Force
Authoring group:
Study Group 1 of the Global Harmonization Task Force
Document type:
Guidance document
Subject area:
Medical device regulation
Geographical scope:
International
Regulatory status:
Non-binding guidance
Intended audience:
Regulatory authorities, conformity assessment bodies, regulated industry
Supersedes:
Definition of the Term “Medical Device”, 2005
Copyright holder:
Global Harmonization Task Force
Year:
2021
Region / city:
International
Subject:
In Vitro Diagnostic (IVD) Medical Devices Classification
Document type:
Guidance document
Author:
IMDRF IVD Working Group
Target audience:
Regulatory Authorities, Conformity Assessment Bodies, Industry
Period of validity:
Not specified
Approval date:
21 January 2021
Amendment date:
Not specified
Copyright holder:
International Medical Device Regulators Forum
Copyright year:
2021
Year:
2025
Region / city:
European Union
Topic:
Health Technology Assessment (HTA)
Document type:
Guideline / Supplementary material
Author:
HTA CG
Target audience:
Health technology assessors, clinical researchers
Period of validity:
Not specified
Approval date:
28 November 2025
Modification date:
Not specified
Year:
2024
Region / city:
Switzerland
Subject:
Clinical performance study for IVD devices
Document type:
Template
Organization:
swissethics
Author:
swissethics
Target audience:
Researchers, Sponsors, Ethics Committees
Period of validity:
Ongoing
Approval date:
27.06.2022
Modification date:
16.09.2024
Date of changes:
24.06.2025
Year:
2022
Region / City:
Not specified
Field:
Endodontics
Document Type:
Research Article
Institution:
Not specified
Author:
Not specified
Target Audience:
Dental researchers, endodontists
Period of Action:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Contextual description:
Research article comparing dentinal crack formation using different rotary file systems for root canal preparation.
Year:
2022
Region / City:
Not specified
Topic:
Bone health, flavonoids, sea buckthorn
Document Type:
Research Table
Institution:
Not specified
Author:
Not specified
Target Audience:
Researchers in pharmacology, bone health, and phytochemistry
Period of Action:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Contextual description
Document type:
Checklist
Subject area:
Medical device regulatory requirements
Device category:
In vitro diagnostic medical devices
Scope:
Design, manufacture, safety, and performance requirements
Regulatory focus:
Essential principles and general safety requirements
Intended use context:
Clinical and laboratory use
Content structure:
General requirements and design and manufacturing requirements
Compliance demonstration:
Methods and supporting controlled documents
Year:
2022
Region / City:
Rwanda
Theme:
Medical Devices Registration
Document Type:
Form
Organization:
Rwanda FDA
Author:
Rwanda FDA
Target Audience:
Applicants for medical device registration
Period of Validity:
From 31 October 2022 to 30 October 2025
Approval Date:
31/10/2022
Date of Revision:
17/10/2022
Review Due Date:
30/10/2025
Year:
2024
Region / City:
European Union
Topic:
In vitro diagnostic medical devices, transitional provisions
Document Type:
Declaration
Organization / Institution:
Manufacturer
Author:
Manufacturer
Target Audience:
Regulatory authorities, notified bodies, manufacturers
Validity Period:
Transition period for medical devices
Approval Date:
N/A
Amendment Date:
N/A
Context Description:
Declaration regarding the transitional provisions for in vitro diagnostic devices under Regulation (EU) 2024/1860, outlining the conditions for continued market placement and conformity assessment procedures.
Year:
Not specified
Region / city:
Not specified
Subject:
Serum protein binding, small proteins
Document type:
Protocol
Organization / institution:
Not specified
Author:
Not specified
Target audience:
Researchers, scientists
Effective period:
Not specified
Approval date:
Not specified
Modification date:
Not specified