WHO Global Model Regulatory Framework for Medical Devices

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

WHO Medical device technical series

WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices, WHO Medical device technical series, Introduction: Medical devices contribute to the attainment of the highest standards of health for individuals.

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.


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Contents

Acronyms and abbreviations 

Acknowledgements 

1 Introduction 

1.1 The WHO Global Model Regulatory Framework for Medical Devices including IVDs 

1.2 Limitations of the WHO Global Model Regulatory Framework for Medical Devices including IVDs 

2. Definition, classification, essential principles and conformity assessment of medical devices

2.1 Definition of medical device and IVD 

2.2 Medical devices classification and classification rules

2.3 Essential principles of safety and performance 

2.3.1 Clinical evidence for non-IVDs 

2.3.2 Assessing conformity to the Essential Principles 

2.4 Special considerations for regulation of IVDs 

2.4.1 Classification of IVDs 

2.4.2 Essential Principles of safety and performance for IVDs 

2.4.3 Clinical evidence for IVDs 

2.4.4 Lot verification testing of IVDs 

3. Enabling conditions for effective regulation of medical devices 

3.1 Legal requirements 

3.2 Gap analysis of existing controls 

3.3 Implementation plan 

3.4 Monitoring implementation 

3.5 Regulatory authority 

3.6 Funding the regulatory system 

3.7 Conflict of interest and impartiality 

3.8 Regulatory competencies and resources 

4. Establishing a stepwise approach to regulating medical devices 

4.1 Stepwise approach 

4.1.1 Reliance and recognition 

4.1.1.1 National responsibilities 

4.1.1.2 International collaboration 

4.2 Basic-level controls and their enforcement 

4.2.1 Publish law, including definition, and regulations with transition period 

4.2.1.1 Establish medical device classification for regulatory purposes 

4.2.1.2 Establish Essential Principles of safety and performance 

4.2.2 Basic-level controls and enforcement – premarket 

4.2.2.1 Establish a basis for reliance and recognition 

4.2.2.2 Establish requirements for declaration of conformity 

4.2.2.3 Establish requirement for manufacturers to have a QMS 

4.2.2.4 Establish requirements for labels and labelling 

4.2.2.5 Prohibit deceptive, misleading and false advertising 

4.2.2.6 Establish provisions for exceptional premarket situations 

4.2.3 Basic-level controls and enforcement – placing on the market 

4.2.3.1 Registration of establishments 

4.2.3.2 Listing of medical devices 

4.2.3.3 Import controls 

4.2.4 Basic-level controls – postmarket 

4.2.4.1 Establish a system for vigilance reporting 

4.2.4.2 Require mandatory notification by the manufacturer of FSCA 

4.2.4.3 Establish a procedure to withdraw unsafe medical devices from the market 

4.2.4.4 Establish procedure to issue safety alerts to users 

4.2.4.5 Undertake market surveillance 

4.3 Expanded-level controls 

4.3.1 Expanded-level controls – premarket 

4.3.1.1 Create oversight of clinical investigations 

4.3.1.2 Appoint and have oversight of CAB 

4.3.1.3 Recognition of standards 

4.3.1.4 Adopt a medical device nomenclature system 

4.3.1.5 Control advertising and promotion 

4.3.2 Expanded level controls – placing on the market 

4.3.2.1 Perform in-country QMS audits 

4.3.2.2 Perform review of submissions for compliance with Essential Principles 

4.3.3 Expanded-level controls – post market 

4.3.3.1 Establish within the regulatory authority processes for post market surveillance and vigilance 

4.3.3.2 Require mandatory reporting of adverse events 

4.3.3.3 Inspections of registered establishments 

4.3.3.4 Provide for testing laboratories 

4.4 Stepwise approach, harmonization, reliance, recognition 

5. Additional topics 

5.1 Determination to establish whether a medical product is a medical device 

5.2 Disposal 

5.3 Donations 

5.4 Reprocessing of single-use medical devices 

5.5 Refurbishing electromedical devices 

5.6 Substandard and falsified products 

5.7 WHO Prequalification Team for IVDs 

5.8 United Nations Population Fund Prequalification Programme for intrauterine devices and condoms 

References 

Further reading 

Appendix 1 

Glossary 

References of the glossary 

Appendix 2 

Hierarchy of regulation 


WHO Global Model Regulatory Framework for Medical Devices

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