WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices

1. Introduction:

Medical devices contribute to the attainment of the highest standards of health for individuals. Without medical devices, common medical procedures – from bandaging a sprained ankle, to diagnosing HIV/AIDS, implanting an artificial hip or any surgical intervention – would not be possible. Medical devices are used in many diverse settings, for example, by laypersons at home, by paramedical staff and clinicians in remote clinics, by opticians and dentists and by health care professionals in advanced medical facilities, for prevention and screening and in palliative care. Such health technologies are used to diagnose illness, to monitor treatments, to assist disabled people and to intervene and treat illnesses, both acute and chronic. Today there are an estimated 2 million different kinds of medical devices on the world market, categorized into more than 22 000 generic devices groups.

In May 2007, the first resolution on health technologies was adopted by the World Health Organization (WHO) World Health Assembly (WHA) (WHA 60.29), which set out the framework for an unprecedented focus on health technologies, but more specifically on medical devices. In 2014, the WHA adopted a resolution regarding regulatory system strengthening for medical products (WHA 67.20). The Resolution states “effective regulatory systems are an essential component of health system strengthening and contribute to better health outcomes”.

In the context of Resolution 67.20, the growing interest in medical devices in the global health community and the lack of regulatory systems for medical devices in many countries, WHO decided to develop this document. It is intended to provide guidance and support to WHO Member States that have yet to develop and implement regulatory controls relating to medical devices, as well as to jurisdictions that are continuing to improve their regulatory frameworks as they take steps to ensure the quality and safety of medical devices available in their countries. This WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices (IVDs) (hereafter referred to as the Model) will provide a basis for such work.

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Table of Contents

Acronyms and abbreviations

Acknowledgements

1. Introduction

2. Definition, classification, essential principles and conformity

assessment of medical devices

3. Enabling conditions for effective regulation of medical devices

4. Establishing a stepwise approach to regulating medical devices

5. Additional topics

References

Further reading