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Clinical Evidence for IVD Medical Devices – Definitions and Principles of Performance Evaluation

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Clinical Evidence for In Vitro Diagnostic Medical Devices

A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Clinical Evidence for In Vitro Diagnostic Medical Devices Working Group is provided below for public comment.

Consultation documents

IMDRF CEIVD WGN91 DRAFT 2026

Thank you for your contribution in reviewing and providing feedback for this document. 

Please provide your feedback through the IMDRF Consultation Hub on Citizen Space by following this link. 

The online response questionnaire will also enable respondents with more than 10 change requests to download a word document which can be uploaded once completed. This comments template is also attached below.

For any concerns regarding this consultation, please contact Annie Truong via email: annie.truong [at] mhra.gov.uk (annie[dot]truong[at]mhra[dot]gov[dot]uk) with the subject line 'Public Consultation on Clinical Evidence for IVD medical devices – Definitions and Principles of Performance Evaluation'. 

Commentary Table - IMDRF CEIVD WGN91 DRAFT 2026

Member sites

Regional harmonization initiatives

APEC Regulatory Harmonization Steering Committee (RHSC)

Pan American Health Organization (PAHO)

African Medical Devices Forum (AMDF)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

The World Health Organization (WHO)

Saudi Arabia, Saudi Food and Drug Authority

Affiliate members

Botswana - Botswana Medicines Regulatory Authority (BoMRA)

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei - Taiwan Food and Drug Administration (TFDA)

Colombia - Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)

Costa Rica - Ministry of Health (MoH)

Cuba - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)

Dominican Republic - General Directorate of Medicines, Food and Health Products (DIGEMAPS)

Egypt - Egyptian Drug Authority  (EDA)

El Salvador - Sanitary Regulation Superintendency (SRS)

Ethiopia - Ethiopian Food and Drug Authority (EFDA)

Ghana - Foods and Drug Authority (Ghana)

India - Central Drugs Standard Control Organization (CDSCO)

Indonesia - Ministry of Health (MoH)

Israel - The Medical Technology, Health Information, Innovation and Research Directorate (MTIIR)

Affiliates

 

Jordan - Jordan Food and Drug Administration (JFDA)

Kenya - Pharmacy and Poisons Board (PPB)

Malaysia - Medical Device Authority (MDA)

Mexico - Federal Commission for Protection from Sanitary Risks (COFEPRIS)

Montenegro - Institute for Medicine and Medical Devices of Montenegro (CINMED)

Nigeria - National Agency for Food and Drug Administration Control (NAFDAC)

Oman - Drug Safety Center, Medical Device Control Department (DSC)

Paraguay - National Health Surveillance (DINAVISA)

Peru - General Directorate of Medicines, Supplies and Drugs (DIGEMID)

Philippines - Food and Drug Administration (FDA)

South Africa - South African Health Products Regulatory Authority (SAHPRA)

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)

Uzbekistan - The Center for Pharmaceutical Products Safety

Zanzibar - Zanzibar Food and Drug Agency (ZFDA)

Zimbabwe - Medicines Control Authority (MCAZ)