ABSTRACT

The profession of public analysis in Nigeria successfully supports numerous public health initiatives, especially those requiring the testing of quality, safety, and efficiency of pharmaceuticals, cosmetics, food, water, chemicals, and medical devices as a preventive intervention procedure for improving public health performance in Nigeria. The government’s policy regarding the Institute’s mandate is clear in this respect; however, the definition of what “Medical Devices” are to be examined under the law of the Institute remains blurred. This paper aims to clarify for the first time any indistinctness regarding what a medical device is under the provisions of the law enabling the practice of public analysis in Nigeria, as well as the types of devices that should be examined for fitness purposes. The study employed the review of secondary data and literature from several pieces of quality standards for its warrant and benchmark to establish the limits of practice of examination of medical devices in line with the provisions of the law of public analysis in Nigeria. The study findings surprisingly revealed that the scope and types of medical devices that public analysts can examine included medical intervention devices such as hospital and clinic devices, laboratory and diagnostic devices, and public health and consumer medical devices.

 

1.     Introduction

Policies, strategies, and action plans for health technologies—especially medical devices—must be a part of every national health plan. The “National Strategic Health Development Plan (NSHDP)” is Nigeria’s national health strategy plan. It summarizes the plan for enhancing the health of Nigerians by reinforcing the healthcare delivery system.

A review of this policy agenda is referred to as “NSHDP II,” which focuses on key health priorities and collaborations with other sectors to address social determinants of health. The singular objective of that strategy plan for health delivery in Nigeria is to achieve the goals of the National Health Policy through a comprehensive approach across all levels of government.[i]

Nigeria’s second National Strategic Health Development Plan (2018-2022) is led by the Federal Ministry of Health and mandated by the National Council on Health. It is the successor to the First National Strategic Health Development Plan (2010-2015), which was extended by a year.[ii]
NSHDP II was developed using a more inclusive and collaborative process than NSHDP I.
The process involved major stakeholders, including the Federal Ministry of Health and Social Welfare, Ministry of Budget and National Planning, Federal Ministry of Finance, Senate and House Committees on Health, all State Ministries of Health, and the FCT Secretariat for Health and Human Services, as well as academia, public health experts, and development partners.[iii]

Access to relevant, reasonably priced, high-quality health products is essential to address health emergencies, develop universal health care, and encourage healthier communities.[iv] Common medical treatments, like bandaging a sprained ankle, diagnosing HIV/AIDS, implanting an artificial hip, and performing surgery, would be impossible without medical equipment. Medical gadgets are utilized in a wide range of situations, including by laypeople at home, paramedical staff and clinicians in remote clinics, opticians and dentists, and healthcare professionals in sophisticated medical facilities for prevention and screening; such health technologies are used to diagnose illnesses, monitor therapies, assist persons with disabilities, and intervene and treat acute and chronic ailments.[v]

In guaranteeing patient safety, medical equipment must undergo biological and chemical safety testing as well as mechanical, functional, and durability testing.[vi] However, the mechanical efficiency test falls out of public analysts’ mandate.[vii] Professional bodies involved in testing the mechanical performance of medical devices are:

1. ASTM International—The American Society for Testing and Materials—develops and publishes consensus technical standards for various materials, products, systems, and services, including those related to medical devices.[viii]
2. Association for the Advancement of Medical Instrumentation (AAMI) is dedicated to developing standards and technical documents to enhance the safety and efficacy of medical devices and health technologies.[ix]

• The International Organization for Standardization (ISO) develops and publishes international standards, including those pertinent to medical devices’ mechanical performance and biocompatibility.[x]

1. U.S. Food and Drug Administration (FDA) provides guidance and recognizes consensus standards for the testing and compliance of medical devices.[xi]

The WHO-Global Model Regulatory Framework for Medical Devices, which includes the In Vitro Diagnostic Medical Devices (GMRF),[xii] helps Member States develop and implement regulatory controls and regional guidelines for good manufacturing to ensure the safety and efficacy of medical devices available in their respective countries. Additionally, the Organization collaborates with Member States and other organizations to offer resources and guidance, such as medical device standards and norms.

As an intervention program, the WHO assists Member States in developing processes to assess national needs for health technologies, namely medical devices. To ensure their availability and usage, particularly in low-resource contexts, a web-based health technology database acts as a clearing house, advising countries on acceptable medical equipment depending on the degree of care, setting, environment, and planned health intervention.[xiii]

Over 7000 generic device groups comprise the estimated 2 million distinct types of medical devices currently available globally.[1]
Any tool, machine, implement, implant, software, material, or other similar or related item that the manufacturer intends to use, alone or in combination, for medical purposes can be considered a medical device.[xiv]

2.     Who is a Public Analyst: In the Context of Nigeria

Public Analysts conduct official testing, among other things, in food safety, environmental analysis, and quality control, ensuring product safety and adherence to regulations.[xv]

A Public Analyst is a professional—typically a chemist or scientist—who works in an official capacity to test and evaluate products such as food, water, drugs, and other consumer goods. Public Analyst’s work is crucial in ensuring that products meet safety, quality, and regulatory standards, and they often provide independent assessments that help protect public health.[xvi]

According to the Laws of the Federation of Nigeria:[xvii]

“A Public Analyst is a registered member of the Institute, who by virtue of his/her knowledge, training, skill, competence, and integrity is authorized by law to analyze consumer and health-related products such as Food, Drugs, Medical Devices, Cosmetics, Water, Chemicals, Chemically and Biologically-based Consumer Products, and issue certificates (a prima facie evidence tenable in any law court or tribunal in Nigeria) regarding their composition, use, quality, safety and efficacy.”

The Federal Ministry of Health oversees the Institute of Public Analysts of Nigeria (IPAN).[xviii] The Institute was created as a professional regulatory authority by IPAN Act CAP.I16 LFN 2004 (formerly Decree No 100 of 1992). Its duties include training, examining, registering, and regulating the activities of analytical laboratories and public analysts in Nigeria (see the Institute’s Law and Laws of the Federation of Nigeria).

In December 2020, the Honorable Minister of State for Health pledged support to the Institute of Public Analysts of Nigeria (IPAN) to realize their goals of better nationwide healthcare services. This initiative by the Minister of State for Health underscores the importance of the Institute and Public Analysts’ significant role in the Nigerian economy’s health sector.[xix]

3.     Medical Devices: Broad Meaning

Examples of medical equipment are simple bedpans, tongue depressors, sophisticated programmable pacemakers, and closed-loop artificial pancreas systems. In vitro diagnostic (IVD) items like reagents, test kits, and blood glucose meters are also considered medical devices. Medical devices also include some radiation-emitting electronic equipment for medical purposes or that makes medical claims. Medical lasers, x-ray machines, and diagnostic ultrasound equipment are some examples.[xx]

In many countries, “medical devices” are traditionally understood as equipment used in hospitals, clinics, or diagnostic laboratories. However, the World Health Organization (WHO)[xxi]  and international regulatory bodies like the US FDA[xxii] and ISO (ISO 13485,[xxiii] ISO 14971[xxiv] ) define medical devices more broadly.

According to the WHO  and the FDA, a medical device is:

“Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article, intended by the manufacturer to be used, alone or in combination, for a medical purpose.”

This definition covers hospital-use devices, laboratory instruments, and public health monitoring tools, such as diagnostic test kits, sterilization equipment, and protective gear.

The FDA  treats a product to be a medical device (FDA regulation)  if it meets the classification as per Section 201(h)  of the Food, Drug, and Cosmetic Act given below:[xxv]

Per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is:

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is:

(A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

(B) intended for use in the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).

4.     Classification and Classification Rules for Medical Devices

There are many different types of medical equipment, and the potential danger to a patient or user might vary greatly. The GMRF recommends that the National Regulatory Authority (NRA) allocate resources and impose controls proportionate to the likelihood of harm associated with medical devices. Regulations should outline how a manufacturer must prove compliance with performance, safety, and quality standards.[xxvi] The degree of regulatory control should rise in proportion to the likelihood that a medical device may injure a patient or user and the seriousness of that injury, that is, the risk it poses.[xxvii] Factors like the degree of invasiveness and length of time a medical device is used in the body determine its risk class.

An overview of the classification schemes and regulatory controls for medical devices[xxviii] and in vitro diagnostic devices (IVDs) in both the United States and the European Union[xxix] is given in section 4.1.

 

 

 

4.1.     United States: FDA Classification and Regulatory Controls[xxx]

Medical devices into three groups by the US FDA depending on the degree of control required to ensure their safety and function during use:

Class I: General Controls

• Devices with low risk to users.
• Subject to general controls such as proper labeling, good manufacturing practices, and device registration.

Most Class I devices are exempted from premarket notification (510(k)).[xxxi]

Class II: General Controls and Special Controls

• Devices with moderate risk.
• In addition to general controls, these devices must comply with special controls like specific labeling requirements, mandatory performance standards, and post-market surveillance.
• Typically require premarket notification (510(k)).[xxxii]

Class III: General Controls and Premarket Approval[xxxiii]

• Devices with high risk or new and not markedly equivalent to existing devices.
• Subject to general controls and must undergo the premarket approval (PMA) process, providing evidence of safety and effectiveness.
• For IVDs, the FDA[xxxiv] applies a similar risk-based classification system. The classification determines the regulatory requirements, including the type of premarket submission or application required.[xxxv]

The impact of an inaccurate result on an individual’s or the public’s health generally determines the risk class of an In-Vitro Diagnostic Medical Device (IVD). A classification scheme for IVDs and medical devices directs the regulatory controls to be put in place for each kind of device.[xxxvi] It is commonly acknowledged that medical devices can be categorized into groups or classes, usually, the four classes—A, B, C, and D.[xxxvii] This is accomplished by applying a set of risk-based classification rules and clearly defining the various conformance assessment processes that ought to be used for each group of devices (Fig.1).[xxxviii] Generally speaking, a piece of medical equipment can be categorized into one risk class.[xxxix] However, the highest class is used if more than one risk class is applicable. It is important to note that as the regulatory requirements increase, so does the scrutiny by the National Regulatory Authority.[2]

Figure 1: Impact of Device Classification on Regulatory Scrutiny

The classification rules for medical devices other than IVDs depend on the features of the device, such as whether it: [xl]

• used as a life-support system
• is an invasive equipment, and its application time
• integrates medicinal products
• includes human or animal tissues or cells
• is an active medical device
• delivers medicinal products, energy, or radiation to a person
• could alter blood or other body fluids
• is used in with another medical device

The classification of medical devices, including IVDs, also considers the technical, scientific, and medical expertise of the intended user—lay person or health care professional.[xli] The use of medical devices by lay persons places specific requirements on the manufacturer to provide necessary ergonomic features to ensure a high likelihood of correct use and to provide information and instruction on the labeling to ensure safe and effective use. For IVDs, the risk classification depends both on the risk to the individual and public health, taking into consideration the following:[xlii]

• the manufacturer’s instructions on the use of the device
• the technical/scientific/medical knowledge of the intended user—layperson or health care professional
• the importance of the information to the diagnosis, which guides the health care professional on decisions to be taken from the natural history of the disease or disorder, including presenting signs and symptoms
• the impact of the result (true or false) on the individual and (or) public health

Regulatory classifications of medical devices can differ.[xliii] For instance, in a country where a disease is endemic, rapid diagnostic tests might be categorized as Class C, whereas in another country, they might be classified as Class B. However, following the globally standardized classification guidelines is generally encouraged.[xliv] Medical device reclassification might be appropriate as device knowledge and expertise grow.[xlv]
When information from science indicates that current controls are insufficient to ensure the device’s performance and safety, the device’s original classification may be altered to a higher-risk class. This is important to public analysts as it ensures that the appropriate test methods[xlvi] are employed to substantiate performance and safety claims.[xlvii]

Reclassification to a lower-risk class may be appropriate if existing scientific data indicates that less stringent controls would offer reasonable assurance of the device’s safety and performance. General reclassification can be performed by revising the categorization rules if they are discovered to be weak, affecting a group of comparable devices.[xlviii]

Alternatively, an individual device may be reclassified by an evidence-based regulatory decision without changing the general classification rules. The NRA may develop explanatory guidance to help manufacturers apply the classification rules. While the manufacturer must primarily classify its medical device, the NRA may review and challenge its decision. Table 2 shows illustrative examples of medical devices and their risk classes. For IVDs, a four-class alphabetical system is recommended to identify the risk-based classes, as shown in Table 1.[3]

 

 

Table 1: Examples of Medical Devices by Risk Class

Table 2: Examples of IVDs by Risk Class

4.2.    Ethics of Safety and Performance Regulations

Medical equipment must meet safety and performance guidelines established by the IMDRF, which have gained widespread acceptance. The manufacturer must prove to the National Rifle Association (NRA) that their product conforms to these guidelines and is designed to function as intended for its lifecycle. These guidelines apply to all medical devices but are unique to certain types like implants, electrically powered devices, and IVDs. The general essential principles of safety and performance for medical devices that apply to all devices include the following:

• The design and production processes should ensure that a medical device, when used according to its intended purpose and by its intended user (layperson or professional), is safe and does not compromise the patient’s clinical condition or the user’s health.
• Medical devices should perform as the manufacturer intended when used under normal/specified conditions.
• As applicable, every medical device, including IVDs, should include or point the user to any performance and safety information that is useful to them or others.
• Identifying known and predictable risks and reducing them in the design, manufacture, and usage of medical equipment are the manufacturer’s risk assessment goals.
• The manufacturer should implement risk control measures to eliminate or appropriately reduce risks.
• The risks envisaged should be weighed against the benefits of the intended purpose.
• If the packing, storage, and transportation guidelines are followed, neither should impact performance or safety.

5.     Import of Conformity Assessments on Medical Devices

From clinical research, product development, and regulatory filing to production, medical device testing, chemical analysis, and scientific assistance from product quality assessors, particularly Public Analysts, makes medical device lifetime possible. Getting safe and effective products to market provides several issues for medical device companies, including characterization of materials, contamination, stability, biocompatibility, problem-solving, failure resolution, and manufacturing quality control. New materials, technologies, and scientific support solutions are essential to a successful product launch as medical device innovation advances to help satisfy patients’ needs related to chronic diseases, an aging global population, and longer life expectancies.[xlix]

6.     Link Between the Definition of a Medical Device, Public Analysis and Analyst

The distinction between a medical device and an in vitro device is lost when not properly explained in the context of international standards.^[4] In assisting in disambiguating what a medical device is and should be, Aronson et al.^[l] defines a medical device as:

“A contrivance designed and manufactured for use in healthcare, and not solely medicinal or nutritional.”

Aronson et al. say that the regulatory classifications of medical devices in place now are intricate and mostly intended for regulators. According to the experts, the regulation of medical devices is not as advanced as that of pharmaceuticals.

They argued that regulations governing medical devices should be comparable to those governing pharmaceuticals, especially devices that incorporate medications, which should be subject to the same regulatory requirements as pharmaceuticals. This would eliminate the disparity that some medication delivery systems are categorized as devices while other comparable systems that provide the same medications are categorized as medicinal items.^[li]

In the context of Public Analysis, what types of medical devices should be evaluated for safety and quality. These two criteria determine the performance characteristics of a medical device. Because public analysts use various methods of instruments and equipment to prove the viability of the use of medical devices, the test methods (see Table 3) listed form a guide in determining which medical device can be tested with such a test method.^[lii] This, in context, would form a foundational guide for Public Analysts or, as explained by the MDCG 2021 – 24 as the notified body,^[liii] especially in Nigeria, to determine the scope and type of medical devices that can be evaluated for viability under the Public Analyst enabling law.^[liv] Medical Device Coordination Group Document (MDCG 2021-24) Guidance on classification of medical devices^[lv] defines what conformity assessment is for medical devices as:

“Conformity assessment is the process demonstrating whether the requirements of the MDR relating to a device have been fulfilled. In the first instance, demonstrating conformity is the manufacturer’s responsibility; for most device classes, the conformity is then assessed by a notified body. The higher the class of the device, the greater the involvement of a notified body in conformity assessment. Annex I (general safety and performance requirements) and Annexes II (technical documentation) and III (technical documentation on post-market surveillance) apply to all devices regardless of class. Further relevant conformity assessment procedures (laid down in Annexes IX to XI) will depend on the class of the device. For some classes, the manufacturer has a choice of more than one procedure. Conformity assessment is described in MDR Article 52. Custom-made or investigational devices falling into any class have their provisions: Annex XIII for custom-made devices and Article 82 for investigational devices. For class III implantable custom-made devices, the manufacturer must apply either Chapter I of Annex IX or Part A of Annex XI.”^[lvi]

 

 

 

 

 

 

 

Table 3: Test Methods Used on Medical Devices^[lvii]

 

 

 

Table 4 gives a contextual classification defined in three tiers.

Table 4: Examples of Medical Devices and Work Place Categories

Table 4 illustrates the traditional view of medical devices and the broader global perspective of the scope of the devices, which this study confirms falls within the framework of public analysis in Nigeria.[lviii]

In other words, diagnostic kits, sterilization tools, and environmental monitoring devices are legally classified as medical devices globally. A deduction can be made from the literature reviewed that a “blood glucose meter is a medical device, but so is a COVID-19 test kit. Both help diagnose or monitor health conditions.” Therefore, summarilly, the scope of and types of the medical devices that falls under the mandate of public analysis in Nigeria are such as stated in table 4.

7.     Conclusion

A vast array of instruments used in diagnostic, therapeutic, and public health applications are included in the classification of medical devices, which goes beyond conventional hospital and clinical equipment. Medical devices are defined clearly by several regulatory frameworks, such as those of the International Organization for Standardization (ISO), US FDA, and the World Health Organization (WHO). However, there is still a lack of awareness in some areas, such as Nigeria, where the term is frequently limited to instruments used in hospitals and laboratories.

This paper has established that public analysts are critical in evaluating various medical devices, particularly those that support public health, environmental monitoring, and consumer safety. In vitro diagnostic (IVD) devices, sterilization tools, personal protective equipment (PPE), and water and food testing kits are all integral to public health protection and thus fall within the broader medical device classification. Recognizing and incorporating this expanded definition within local regulatory and professional practices enhances the effectiveness of quality assurance frameworks, improves consumer safety, and aligns national policies with global best practices. Future efforts should focus on harmonizing local regulations with international standards to ensure a more comprehensive and inclusive approach to medical device evaluation and oversight.

8.     Recommendations

Based on the findings of this study, the following recommendations are proposed to enhance the scope and effectiveness of medical device assessment by public analysts in Nigeria:

1. Clarification and Expansion of Regulatory Definitions
   Regulatory authorities in Nigeria should adopt a more comprehensive definition of medical devices, aligning with international standards such as those of the ISO, USFDA, and WHO. This will help eliminate ambiguities and ensure that public analysts can assess a wider range of devices beyond conventional hospital equipment.
2. Strengthening the Role of Public Analysts in Medical Device Evaluation
   Public analysts should be recognized as key players in assessing medical devices impacting public health, environmental monitoring, and consumer safety. This includes in vitro diagnostic (IVD) devices, sterilization tools, personal protective equipment (PPE), and food and water testing kits.
3. Harmonization of Local Regulations with International Standards
   Efforts should be made to align Nigeria’s regulatory framework with global best practices to ensure consistency in quality assurance processes. This can be achieved through collaboration with international regulatory bodies and adopting globally accepted testing methodologies.
4. Capacity Building and Training for Public Analysts
   Public analysts should receive continuous professional training on evolving medical technologies, regulatory updates, and standardized testing protocols to assess medical devices effectively. This will enhance their ability to conduct thorough quality and safety assessments.
5. Public Awareness and Stakeholder Engagement
   Increased awareness campaigns should be conducted to educate policymakers, healthcare professionals, and industry stakeholders on the broad classification of medical devices. This will facilitate better regulatory enforcement and encourage quality and safety standards compliance.
6. Further Research and Development
   Future studies should explore the practical challenges faced in medical device testing within Nigeria’s public analysis framework. Additionally, research should focus on developing localized testing guidelines to address context-specific regulatory needs.

By implementing these recommendations, public analysts can improve public health outcomes, align its regulatory methods with international standards, and improve the effectiveness of its medical device assessment system in Nigeria.

 

 

 

 

 

 

 

 

 

 

 

 

[1] US FDA, “Product Classification: Medical Devices,” US Dept. of Health and Human Services, accessed February 4, 2025, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.

[2] Federal Institute for Drugs and Medical Devices, “Differentiation and Classification.”

[3] “WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices, Annex 3,” 198–199.

[4] WHO, “WHO Global Model Regulatory Framework for Medical Devices Including In vitro Diagnostic Medical Devices.”

[i] ‘Stakeholders Validate National Strategic Health Development Plan for Cohesive Implementation Framework | WHO | Regional Office for Africa’, 6 February 2025, https://www.afro.who.int/news/stakeholders-validate-national-strategic-health-development-plan-cohesive-implementation.

[ii] ‘Health – OSGF’, accessed 7 February 2025, https://www.osgf.gov.ng/resources/policies/health/.

[iii] FMoHSW, ‘Second National Strategic Health Development Plan 2018 – 2022’ (Federal Ministry of Health and Social Welfare, 2018), https://extranet.who.int/countryplanningcycles/sites/default/files/public_file_rep/NGA_Nigeria_Second-National-Strategic-Health-Development-Plan_2018-2022.pdf.

[iv] ‘Medical Devices’, accessed 4 February 2025, https://www.who.int/health-topics/medical-devices.

[v] ‘Medical Devices’, accessed 4 February 2025, https://www.who.int/health-topics/medical-devices.

[vi] Tentamus, ‘Medical Device Testing’, Tentamus Group, accessed 4 February 2025, https://www.tentamus.com/lab-analyses/medical-device-testing/.

[vii] Intertek, ‘Medical Device Problem Solving’, accessed 25 February 2025, https://www.intertek.com/analytical-laboratories/materials/medical-device/.

[viii] ASTM International, ‘Medical Device Standards and Implant Standards’, Technical Inforamtion, 2025, https://www.astm.org/products-services/standards-and-publications/standards/medical-device-standards-and-implant-standards.html?utm_source=chatgpt.com.

[ix] Association for the Advancement of Medical Instrumentation, ‘AAMI Main Page’, Default, accessed 25 February 2025, https://www.aami.org.

[x] ISO, ‘ISO 10993-1:2018’, ISO, accessed 25 February 2025, https://www.iso.org/standard/68936.html.

[xi] Center for Devices and Radiological Health, ‘Medical Devices’, FDA (FDA, 30 December 2024), https://www.fda.gov/medical-devices.

[xii] WHO Expert Committee on Biological Standardization Seventy-sixth report WHO, ‘WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices’ (World Health Organization, 22 March 2023), Annex 3, https://cdn.who.int/media/docs/default-source/biologicals/ecbs/annex3-gmrf-who_trs_1045.pdf?sfvrsn=88867b3a_3&download=true.

[xiii] ‘Medical Devices’.

[xiv] ‘Medical Devices’, accessed 4 February 2025, https://www.who.int/health-topics/medical-devices.

[xv] APA, ‘The Association of Public Analysts’, Publicanalysts.com, accessed 5 February 2025, http://www.publicanalyst.com/about_us/.

[xvi] ‘Public Analyst Scientific Services | Minton Treharne & Davies’, Minton Treharne & Davies Group – Providing Consultancy, Analysis & Testing, Training & Certification Services to Industry (blog), accessed 5 February 2025, https://www.minton.group/analysis-testing/public-analyst.

[xvii] ‘IPAN | Institute of Public Analysts of Nigeria’, accessed 4 February 2025, https://www.ipan.gov.ng/.

[xviii] ‘IPAN | Institute of Public Analysts of Nigeria’.

[xix] FMoHSW, ‘Better Nationwide Healthcare Services: Dr. Mamora Pledges Support to Institute of Public Analysts of Nigeria’, accessed 5 February 2025, https://site.health.gov.ng/pr64.

[xx] US FDA, ‘Product Classification: Medical Devices’.

[xxi] Center for Devices and Radiological Health, ‘How to Determine If Your Product Is a Medical Device’, FDA, 14 August 2023, https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device.

[xxii] US FDA, ‘Product Classification: Medical Devices’.

[xxiii] ISO, ‘ISO 13485:2016’, ISO, accessed 4 February 2025, https://www.iso.org/standard/59752.html.

[xxiv] ISO, ‘ISO 14971:2019’, ISO, accessed 4 February 2025, https://www.iso.org/standard/72704.html.

[xxv] Office of the Commissioner, ‘Classification of Products as Drugs and Devices and Additional Product Classification Issues’ (FDA, 12 May 2021), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/classification-products-drugs-and-devices-and-additional-product-classification-issues.

[xxvi] Julian M. Goldman, Sandy Weininger, and Micheal B. Jaffe, ‘Applying Medical Device Informatics to Enable Safe and Secure Interoperable Systems: Medical Device Interface Data Sheets’, ResearchGate, 22 October 2024, https://doi.org/10.1213/ANE.0000000000004251.

[xxvii] Bruna De Lucca Caetano, ‘Medical Device Technical File (Technical Documentation)’, SimplerQMS, 12 January 2024, https://simplerqms.com/medical-device-technical-file/.

[xxviii] Germany Federal Institute for Drugs and Medical Devices, ‘Differentiation and Classification’, Federal Institute for Drugs and Medical Devices, accessed 12 February 2025, https://www.bfarm.de/EN/Medical-devices/Tasks/Differentiation-and-classification/_node.html.

[xxix] Medical Device Coordination Group, ‘Guidance on Classification of Medical Devices’ (Medical Device Coordination Group (MDCG), October 2021), Medical Device Coordination Group Document, https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf.

[xxx] Center for Devices and Radiological Health, ‘Classify Your Medical Device’, FDA (FDA, 14 August 2023), https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device.

[xxxi] Center for Devices and Radiological Health, ‘Class I and Class II Device Exemptions’, FDA, 9 August 2024, https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions.

[xxxii] Health.

[xxxiii] Center for Devices and Radiological Health, ‘Regulatory Controls (Class III)’, FDA (FDA, 15 August 2023), https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls.

[xxxiv] ‘CFR – Code of Federal Regulations Title 21’, US FDA, accessed 4 February 2025, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm.

[xxxv] Medical Device Coordination Group Document, ‘Guidance on Classification Rules for in Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746’ (Medical Device Coordination Group Document, July 2024), https://health.ec.europa.eu/document/download/12f9756a-1e0d-4aed-9783-d948553f1705_en?utm_source=chatgpt.com.

[xxxvi] Medical Device Coordination Group Document.

[xxxvii] Medical Device Coordination Group, ‘Guidance on Classification of Medical Devices’.

[xxxviii] Fission Focus, ‘How to Classify Medical Devices: A Beginner’s Guide’, 13 June 2024, https://www.linkedin.com/pulse/how-classify-medical-devices-beginners-guide-getfission-kkqzc/.

[xxxix] European Commission, ‘Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices’, 22 May 2019, https://ec.europa.eu/docsroom/documents/35582.

[xl] Center for Devices and Radiological Health, ‘Classify Your Medical Device’, FDA (FDA, 14 August 2023), https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device.

[xli] ‘WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices, Annex 3’, accessed 5 February 2025, https://www.who.int/publications/m/item/who-global-model-regulatory-framework-for-medical-devices-including-in-vitro-diagnostic-medical-devices–annex-3.

[xlii] Mika Reinikainen and Dr Maurizio Suppo, ‘Explaining IVD Classification Issues’, BSI National Standards Body, 2022, 2, https://doi.org/BSI/UK/1644/ST/1019/EN/AS.

[xliii] WHO Expert Committee on Biological Standardization Seventy-sixth report WHO, ‘WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices’ (World Health Organization, 22 March 2023), Annex 3, https://cdn.who.int/media/docs/default-source/biologicals/ecbs/annex3-gmrf-who_trs_1045.pdf?sfvrsn=88867b3a_3&download=true.

[xliv] Medical Device Coordination Group, ‘Guidance on Classification of Medical Devices’ (Medical Device Coordination Group (MDCG), October 2021), Medical Device Coordination Group Document, https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf.

[xlv] WHO, ‘WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices’, 198.

[xlvi] Tentamus, ‘Medical Device Testing’, Tentamus Group, accessed 4 February 2025, https://www.tentamus.com/lab-analyses/medical-device-testing/.

[xlvii] Bruna De Lucca Caetano, ‘Medical Device Technical File (Technical Documentation)’, SimplerQMS, 12 January 2024, https://simplerqms.com/medical-device-technical-file/.

[xlviii] Center for Devices and Radiological Health, ‘Reclassification’, FDA, 8 November 2024, https://www.fda.gov/about-fda/cdrh-transparency/reclassification.

[xlix] Intertek, ‘Medical Device Testing and Scientific Support Services’, accessed 5 February 2025, https://www.intertek.com/medical/scientific-support/.

[l] Jeffrey K. Aronson, Carl Heneghan, and Robin E. Ferner, ‘Medical Devices: Definition, Classification, and Regulatory Implications’, Drug Safety 43, no. 2 (February 2020): 83–93, https://doi.org/10.1007/s40264-019-00878-3.

[li] Aronson, Heneghan, and Ferner.

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[lvi] Medical Device Coordination Group, 5.

[lvii] Tentamus, ‘Medical Device Testing’.

[lviii] US FDA, ‘Product Classification: Medical Devices’, US Dept. of Health and Human Services, accessed 4 February 2025, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.