Priority Medical Devices

What are priority medical devices?

Priority medical devices encompass a wide range of technologies deemed essential for addressing key health challenges, improving healthcare delivery, and achieving universal health coverage (UHC) goals. These devices span various medical specialities and healthcare domains. They are selected based on their potential to address critical health needs, enhance healthcare accessibility and equity, and contribute to attaining health-related Sustainable Development Goals (SDGs) and Universal Health Coverage (UHC).

The World Health Organisation (WHO) identifies priority medical devices based on their potential impact on public health, disease burden, and healthcare delivery in low- and middle-income countries (LMICs). WHO’s priority medical devices include preventative, diagnostic, therapeutic, monitoring and rehabilitation devices.

According to the Global Atlas of Medical Devices published in 2022, more than 2 million MDEs are available for disease prevention, diagnosis, treatment and rehabilitation¹. However, most MDEs are designed for use in high-resource settings and are unsuitable for deployment in facilities with fluctuating electricity and internet services, limited water supply and waste management and extreme operating conditions².

The agenda of the World Health Organisation (WHO) led Global Initiative on Health Technologies (GIHT) aims to improve access to appropriate MDEs that meet the “5 As” criteria:

• Availability
• Assured (Quality)
• Accessibility
• Appropriateness
• Affordability.

Developing technical requirements aims to address critical health needs, improve access to essential medical devices, and enhance patient care in LMICs.

The WHO and other implementation partners maintain multiple lists of priority medical devices for low-resource settings, including:

• WHO Technical Specifications for 61 Medical Devices
• WHO Technical Specifications for 13 Medical Devices on UN Life-Saving Commodities
• Interagency list of priority medical devices for essential interventions for reproductive, maternal, newborn and child health
• WHO list of priority medical devices for the management of cardiovascular diseases and diabetes
• WHO list of priority medical devices for cancer management
• The selection and use of essential in vitro diagnostics
• WHO Compendium of Innovative Health Technologies for Low-resource Settings 2022

These priority medical device lists have been developed based on clinical guidelines established for priority health interventions designed for low-resource settings, including:

• Integrated Management of Childhood Illness (IMCI)^3-5 for the diagnosis and treatment of infectious diseases and acute illness in children under five years of age
• Integrated Management of Adult Illness (IMAI)^{4, 6, 7} for the diagnosis and treatment of infectious diseases and acute illness in adults over 16 years of age
• Package of Essential Non-Communicable Disease Intervention (PEN)^8-10 for the diagnosis and treatment of leading cardiovascular and respiratory diseases, cancer and diabetes¹¹.
• PEN-Plus¹² extends PEN by incorporating integrated chronic care for severe NCDs such as Type 1 Diabetes, Rheumatic Heart Disease (RHD), and Sickle Cell Disease (SCD).
• Global report on assistive technology¹³

These guidelines focus on delivering care at the lowest levels of the healthcare system. However, they are widely recognised as an incomplete solution for acute and chronic disease management, as highlighted by recent research from the Non-Communicable Disease and Injury Poverty (NCDI-Poverty) Commission^{14, 15} and the WHO Independent High-level Commission on NCDs¹⁶. The COVID-19 pandemic also revealed deficiencies in the clinical management of infectious diseases and access to critical MDEs in LMICs, triggering the release of new guidelines and priority MDE lists^17-19.

MeDevIS medical device platform

The MeDevIS (Medical Devices Information System) platform is an online database developed by the World Health Organization (WHO) to facilitate the exchange of information on medical devices. MeDevIS is a centralised platform for sharing data, technical specifications, regulatory information, and best practices related to medical devices among WHO member states, regulatory authorities, healthcare providers, manufacturers, and other stakeholders.

Key features of the MeDevIS WHO platform include:

• Data Sharing: MeDevIS allows users to upload, access, and share data on medical devices, including product details, specifications, classifications, and regulatory approvals. This enables stakeholders to exchange information and collaborate on medical device procurement, regulation, and management issues.
• Technical Information: MeDevIS provides technical information and resources on medical devices, such as guidelines, standards, and training materials. Users can access technical documents, reports, and publications to support decision-making, capacity-building, and regulatory compliance in medical device-related activities.
• Regulatory Support: MeDevIS offers regulatory support tools and resources to assist countries in strengthening their regulatory systems for medical devices. This includes information on regulatory frameworks, guidance documents, and best practices for medical device registration, evaluation, and oversight.
• Capacity Building: MeDevIS is a platform for capacity-building initiatives, training programs, and knowledge exchange activities on medical device regulation, quality assurance, and safety monitoring. Users can access educational materials, webinars, and workshops to enhance their skills and expertise in managing medical devices.
• Global Collaboration: MeDevIS fosters global collaboration and networking among medical device regulation and management stakeholders. It facilitates communication, collaboration, and partnerships to address common challenges, share lessons learned, and promote best practices in medical device governance and oversight.

Impact and significance

The development of technical specifications for priority medical devices by WHO has significant implications for healthcare systems and populations worldwide. By providing clear and evidence-based guidance on device selection, procurement, and utilisation, WHO’s technical specifications enable healthcare providers to make informed decisions regarding adopting and integrating medical technologies into clinical practice. Technical specifications also support procurement agencies and health ministries in conducting transparent and competitive procurement processes, ensuring the acquisition of high-quality, cost-effective medical devices that meet the needs of healthcare facilities and patient populations.

Furthermore, WHO’s technical specifications contribute to the harmonisation and standardisation of medical devices across different healthcare settings and regions, facilitating device interoperability, compatibility, and exchangeability. This interoperability is essential in global health emergencies and humanitarian crises, where rapid deployment of medical technologies and interoperable systems is essential for effective response and patient care. Additionally, WHO’s technical specifications help bridge the gap between innovation and access by promoting the development and adoption of affordable, context-appropriate medical devices that address the specific health needs of low-resource settings and underserved populations.

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