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WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

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International (WHO Member States)
vWHO Technical Report Series No. 1045 (2023), Annex 3; replaces Annex 4 of TRS No. 1003 (2017)
7 domains
53 controls

The WHO Global Model Regulatory Framework for medical devices and IVDs (2023): what national law should require of manufacturers, authorized representatives, importers and distributors (classification, essential principles, clinical evidence, QMS, declaration of conformity, labelling, registration, listing, UDI, vigilance and field actions) and how governments and regulators should legislate, resource and build controls stepwise, from basic to expanded oversight.

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WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices is a compliance framework from International (WHO Member States) with 7 domains and 53 controls. The largest domains are Recommendations to NRAs: pre-market, market and post-market oversight, pathways and implementation – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices (13 controls), Special products and situations: clinical investigations, emergency use, combination products, companion diagnostics, software, reprocessing, refurbishing, donations, disposal and falsified devices – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices (11 controls), Manufacturer obligations: essential principles, technical documentation, clinical evidence, QMS, declaration of conformity, labelling and promotion – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices (8 controls). Every control below carries what it requires and what an assessor expects to see.

Maintained by Gerard Blokdyk

Framework summaries on this platform are interpretations grounded in the published source, for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.

Framework Domains (7)

Manufacturer obligations: essential principles, technical documentation, clinical evidence, QMS, declaration of conformity, labelling and promotion – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

8 controls
Controls in the Manufacturer obligations: essential principles, technical documentation, clinical evidence, QMS, declaration of conformity, labelling and promotion – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices domain of WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices: 8 controls
CodeTitle
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::4.3-EPShow that every device conforms to the applicable essential principles of safety and performance throughout its life cycle, preferably by applying recognised international standards
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::4.3-changesKeep changes to intended purpose, design, specifications, labelling or manufacture in conformity with the essential principles, classify changes as substantial or not under a procedure, and seek further evaluation where required
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::4.3.1-clinicalCompile clinical evidence and a documented clinical evaluation under the QMS as part of the technical documentation, with new data for novel high-risk devices and investigations to ISO 14155
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::4.4.3-IVDFor IVDs, establish clinical evidence covering scientific validity, analytical performance and clinical performance, with performance studies on human specimens to ISO 20916
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.2.2-DoCDraw up, hold and supply on request a signed declaration of conformity for each device with the minimum content, and keep the supporting technical documentation available for verification
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.2.3-QMSEstablish and maintain, for every device class, a QMS with records suited to the processes and products, aligned with ISO 13485 and ISO 14971 at their latest editions
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.2.4-labellingProvide labels and instructions suited to the intended user and in an accepted language, with intended purpose, contraindications, warnings, identification for traceability, UDI where required and manufacturer and importer details matching registration
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.2.5-advertisingAdvertise and promote devices only within their authorized intended purpose, with evidence-backed claims, to appropriate audiences, and never falsely, misleadingly or deceptively

Placing on the market: establishment registration, authorized representatives, importers and distributors, listing, import documents, UDI and distribution – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

8 controls
Controls in the Placing on the market: establishment registration, authorized representatives, importers and distributors, listing, import documents, UDI and distribution – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices domain of WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices: 8 controls
CodeTitle
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.3-ARA manufacturer outside the jurisdiction appoints a local authorized representative, under an agreement setting out who meets each national requirement and keeps distribution records
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.3.1-registrationRegister each local manufacturer, authorized representative, importer and distributor establishment with the NRA, with a separate registration for each role, and notify significant changes promptly
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.3.1.1-AR-dutiesAs authorized representative, give the NRA business and contact details, list devices and keep the list current, support authorization applications, relay feedback and FSCA, cooperate with importers, distributors and the NRA and see that users are trained
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.3.1.2-importerImporters and distributors register, supply only conforming devices with proper labelling and instructions, pass feedback and complaints to the manufacturer or representative, keep traceability and follow the manufacturer's storage, handling, transport and maintenance requirements
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.3.2-listingSubmit and keep current a listing of each device placed on the national market, using an internationally recognised nomenclature and information consistent with the technical documentation
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.3.3-importSupply the import documentation the NRA requires (QMS certificates, proof of authorization in the exporting country, declaration of conformity, test reports), import through designated ports and do not release devices without NRA authorization
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.3.1.5-UDIWhere the NRA adopts UDI, assign UDI-DIs and UDI-PIs through an accredited issuing agency, apply them to labels and packaging in human- and machine-readable form, and submit UDI-DI data with a nomenclature term to the UDI database
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.3.3.3.1-distributionManufacturers select and contract qualified distributors and specify storage, handling, transport, installation, servicing, traceability and disposal requirements; distributors run a basic QMS and follow good distribution practice

Post-market obligations: adverse events, field safety corrective actions, withdrawals and post-market surveillance – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

4 controls
Controls in the Post-market obligations: adverse events, field safety corrective actions, withdrawals and post-market surveillance – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices domain of WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices: 4 controls
CodeTitle
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.4.1-AEReport to the NRA serious public health threats, deaths or serious deteriorations in health, and failures or design, labelling or use problems that could cause them, plus any false negative for a Class D IVD; investigate reports passed on by the NRA and report the outcome
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.4.2-FSCANotify the NRA promptly of every field safety corrective action undertaken in the country, issue field safety notices, and allow the NRA to monitor the effectiveness of corrective actions
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.4.3-withdrawalCooperate with NRA enforcement against unsafe or non-compliant devices, including withdrawal, quarantine and disposal, and review technical documentation and revise labelling when unforeseen harm shows it is inadequate
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.3.3.1-PMSOperate post-market surveillance within the QMS that collects user feedback, reviews the benefit-risk profile, reports the required events, evaluates and takes corrective action, with importers and distributors keeping feedback records

Purpose, terminology, definitions and risk classification – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

1 controls
Controls in the Purpose, terminology, definitions and risk classification – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices domain of WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices: 1 controls
CodeTitle
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::4.2-classifyManufacturers classify each device and IVD by the harmonized risk-based rules, applying the higher class where two could apply, and accept that the NRA may review or overturn the class

Recommendations to NRAs: pre-market, market and post-market oversight, pathways and implementation – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

13 controls
Controls in the Recommendations to NRAs: pre-market, market and post-market oversight, pathways and implementation – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices domain of WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices: 13 controls
CodeTitle
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.3-NRA-registersNRA: run establishment registration and device listing systems, check them periodically, publish them, and specify listing data and nomenclature
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.3.3-NRA-importNRA: decide which device categories need extra import controls, train customs, designate ports of entry, and hold powers to stop non-compliant imports
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.4-NRA-vigilanceNRA: run a reporting system for adverse events from manufacturers, users and patients, forward reports for investigation, assess risks, exchange information with other NRAs, issue safety alerts and publish a notices repository
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.4.3-NRA-enforceNRA: enforce against non-compliant, unsafe or falsified devices with proportionate measures, consult manufacturers before public alerts, inform the public and share concerns with the auditing NRA or CAB
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.4.5-6.3.3.2-MSNRA: conduct risk-based market surveillance using distribution-chain risk, user feedback and manufacturer surveillance data, with focused sampling and testing through collaborating laboratories
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.3.1-NRA-premarketNRA: oversee clinical investigations, recognise and supervise CABs, adopt a nomenclature system and a UDI system aligned with international practice, and control advertising
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.3.2-NRA-reviewNRA: verify manufacturers' QMS by audit or reliance on valid certificates, review submissions against transparent criteria using harmonized formats, apply extended review triggers, and handle changes with guidance
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.3.3.3-NRA-inspectNRA: inspect registered establishments on a risk basis (scheduled or unannounced), rely on trusted inspections where possible, and license, suspend or withdraw registrations for uncorrected nonconformities
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.3.3.4-localGovernment and NRA: support quality local production with good regulatory practice, apply the same controls to local and imported devices, offer pre-submission meetings and impartial technical support, and inspect local plants
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.3.3.5-testingNRA: avoid routine testing, use accredited laboratories (ISO/IEC 17025, ISO 15189) under defined agreements or reliance for targeted testing of falsified, incident-related, priority or lot-verification samples
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::7.3-7.6-NRA-pathwaysNRA: establish emergency use authorization criteria and validity limits, borderline product and combination product designation processes with published decisions and appeal, and a donation authorization mechanism and policy
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::8.2-8.4-NRA-policyNRA: set policy on reprocessing single-use devices and refurbishing, and build oversight of SaMD and machine learning devices, including local dataset representativeness, update and cybersecurity risks and real-world evidence
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::9.1-stakeholdersGovernment and NRA: involve stakeholders throughout the regulatory process and assess the public health, economic and social impact of proposed controls

Recommendations to governments and NRAs: legal basis, NRA set-up, resources, reliance and the stepwise controls – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

8 controls
Controls in the Recommendations to governments and NRAs: legal basis, NRA set-up, resources, reliance and the stepwise controls – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices domain of WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices: 8 controls
CodeTitle
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::5.1-lawGovernment: give device regulation a sound legal basis that defines products and regulated parties, requires only safe, performing, quality devices on the market, empowers and holds the NRA accountable, and coordinates with justice, police and customs
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::5.2-5.4-planGovernment and NRA: carry out a gap analysis with stakeholders, publish a risk-based implementation plan aligned with resources, and monitor implementation with indicators (such as the WHO global benchmarking tool) reported publicly
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::5.5-5.7-NRAGovernment: appoint an NRA with independent decision-making, defined governance and public performance reporting, adequate and transparent funding (fair, reviewed user fees if any), and a code of conduct and conflict-of-interest policy
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::5.8-9.3-capacityNRA: build and maintain regulatory competence through recruitment, retention, formal selection and annual training plans, evidence of staff competence, expert committees and external expertise
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::5.9-relianceGovernment and NRA: provide in law for reliance on and recognition of reference regulators, CABs and WHO, keep national-only functions in-country, and join information-sharing networks
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.1-stepwiseNRA: implement controls stepwise, enforcing the basic-level controls before adopting expanded-level ones, and only when the legal basis and resources exist
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.1.1-6.2.1.2-NRANRA: adopt a harmonized risk classification scheme with guidance and a voluntary classification consultation, require declarations of conformity with the essential principles, and recognise standards for presumption of conformity
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.2.2.6-exceptionsGovernment and NRA: define exemptions and enforcement discretion for emergencies, humanitarian use, individual patients, clinical investigations, exhibitions and donations, with risk-benefit evaluation and clear guidance

Special products and situations: clinical investigations, emergency use, combination products, companion diagnostics, software, reprocessing, refurbishing, donations, disposal and falsified devices – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

11 controls
Controls in the Special products and situations: clinical investigations, emergency use, combination products, companion diagnostics, software, reprocessing, refurbishing, donations, disposal and falsified devices – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices domain of WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices: 11 controls
CodeTitle
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::4.4.4-lotSupport NRA-required lot verification testing of high-risk (Class D) IVDs and control transport and storage so lot performance is not affected
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::6.3.1.1-CISponsors obtain prior NRA authorization for new clinical investigations, run them under ethics committee oversight with informed consent to ISO 14155, and report progress and serious incidents
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::7.3-EUAApplicants for emergency use authorization submit the evidence available, keep seeking and submitting new evidence, monitor post-market safety and performance, and move to full assessment within the limited validity period
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::7.5-combinationFor medicine-device combination products, follow the designated regulatory pathway (by primary mode of action), meet the GMP or QMS, verification and post-market requirements set for the product, and show safety and performance of the whole with quality of the medicinal substance
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::7.6-donationsDonors ensure donated devices meet the receiving country's requirements, respond to an expressed clinical need, are complete, documented in a local language, suited to local conditions and skills, have adequate shelf life and come with a disposal plan, and obtain import authorization before shipment
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::8.1-disposalGive users decontamination and disposal instructions, and dispose of devices at end of life (or earlier if hazardous) safely in line with manufacturer recommendations and local rules
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::8.2-reprocessingDo not reuse single-use devices except under NRA-permitted conditions; an entity reprocessing them becomes the manufacturer, with risk assessment, validated reprocessing, a QMS, traceability, labelling as reprocessed and incident reporting
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::8.3-refurbishingRefurbishers meet the same requirements as original manufacturers (QMS certificate, technical documentation, declaration of conformity) and identify refurbished devices as such on labelling and commercial documents
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::8.4-SaMDFor SaMD and software in devices, including machine learning devices, demonstrate scientific validity, analytical validity and clinical performance, run life-cycle processes under a QMS, manage updates, cybersecurity and data quality, and monitor performance after deployment
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::8.5-SFReport suspected substandard or falsified devices to the NRA, buy and distribute only through reliable sources, and use UDI and track-and-trace tools to protect supply chain integrity
who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices::8.6-CDxFor companion diagnostics, obtain authorization for clinical performance studies and market entry, label the corresponding medicine where the test is tied to it, and report test failures to the device regulator (and medicine impacts to the medicine regulator)

What is WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices and who does it apply to?

WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices is a compliance framework from International (WHO Member States) with 7 domains and 53 controls. The WHO Global Model Regulatory Framework for medical devices and IVDs (2023): what national law should require of manufacturers, authorized representatives, importers and distributors (classification, essential principles, clinical evidence, QMS, declaration of conformity, labelling, registration, listing, UDI, vigilance and field actions) and how governments and regulators should legislate, resource and build controls stepwise, from basic to expanded oversight. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

What does WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices actually require?

WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices has 53 controls organised across 7 domains. The largest domains are Recommendations to NRAs: pre-market, market and post-market oversight, pathways and implementation – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices (13 controls), Special products and situations: clinical investigations, emergency use, combination products, companion diagnostics, software, reprocessing, refurbishing, donations, disposal and falsified devices – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices (11 controls), Manufacturer obligations: essential principles, technical documentation, clinical evidence, QMS, declaration of conformity, labelling and promotion – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices (8 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

If I already comply with another framework, how much of WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices do I already cover?

WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices does not currently have cross-framework mappings in our system. Check back as we continuously expand our mapping database.

How do I implement WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices?

Start your WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 53 controls and track your progress.

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