Medical Device Regulatory Practices: An International Perspective


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Describe the key principles associated with the control and regulation of the medical devices industry. Relate the approvals process and ethical issues of medical device design to a non technical or multidisciplinary audience. The students will be required to investigate the standards and legal requirements for a medical device.

The output of this assignment will be a report on the regulatory requirements for the device which identifies the key stages for certification. Enderle, Susan M. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country.

As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as c. Medical devices vary in both their intended use and indications for use.

Examples range from simple, low-risk devices such as tongue depressors , medical thermometers , disposable gloves , and bedpans to complex, high-risk devices that are implanted and sustain life. One example of high-risk devices are those with Embedded software such as pacemakers, and which assist in the conduct of medical testing , implants , and prostheses.

Items as intricate as housings for cochlear implants are manufactured through the deep drawn and shallow drawn manufacturing processes. The design of medical devices constitutes a major segment of the field of biomedical engineering. Although collectively Europe has a larger share, Japan has the second largest country market share.

The largest market shares in Europe in order of market share size belong to Germany, Italy, France, and the United Kingdom. The rest of the world comprises regions like in no particular order Australia, Canada, China, India, and Iran. This article discusses what constitutes a medical device in these different regions and throughout the article these regions will be discussed in order of their global market share. A global definition for medical device is difficult to establish because there are numerous regulatory bodies worldwide overseeing the marketing of medical devices.

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Although these bodies often collaborate and discuss the definition in general, there are subtle differences in wording that prevent a global harmonization of the definition of a medical device, thus the appropriate definition of a medical device depends on the region. Often a portion of the definition of a medical device is intended to differentiate between medical devices and drugs , as the regulatory requirements of the two are different.

Definitions also often recognize In vitro diagnostics as a subclass of medical devices and establish accessories as medical devices. The term 'device' does not include software functions excluded pursuant to section o. Based on the New Approach , rules that relate to safety and performance of medical devices were harmonised in the EU in the s. The New Approach , defined in a European Council Resolution of May , [8] represents an innovative way of technical harmonisation.

It aims to remove technical barriers to trade and dispel the consequent uncertainty for economic operators, to facilitate free movement of goods inside the EU. They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. The government of each Member State must appoint a competent authority responsible for medical devices.

The competent authority CA is a body with authority to act on behalf of the member state to ensure that member state government transposes requirements of medical device directives into national law and applies them. The CA reports to the minister of health in the member state.


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The CA in one Member State has no jurisdiction in any other member state, but exchanges information and tries to reach common positions. In the EU, all medical devices must be identified with the CE mark. In September , the European Commission proposed new legislation aimed at enhancing safety, traceability, and transparency. Article 2, Paragraph 4, of the Pharmaceutical Affairs Law PAL [11] defines medical devices as "instruments and apparatus intended for use in diagnosis, cure or prevention of diseases in humans or other animals; intended to affect the structure or functions of the body of man or other animals.

The term medical device, as defined in the Food and Drugs Act , is "any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in: the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in a human being; the restoration, correction or modification of a body function or the body structure of a human being; the diagnosis of pregnancy in a human being; or the care of a human being during pregnancy and at and after the birth of a child, including the care of the child.

It also includes a contraceptive device but does not include a drug. The term covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Health Canada reviews medical devices to assess their safety, effectiveness, and quality before authorizing their sale in Canada.

The regulatory authorities recognize different classes of medical devices based on their potential for harm if misused, design complexity, and their use characteristics. Each country or region defines these categories in different ways. The authorities also recognize that some devices are provided in combination with drugs, and regulation of these combination products takes this factor into consideration.

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Classifying medical devices based on their risk is essential for maintaining patient safety while simultaneously facilitating marketing of medical products. By establishing different risk classifications, lower risk devices, for example a stethoscope or tongue depressor, are not required to undergo the same level of testing that higher risk devices such as artificial pacemakers undergo. Establishing a hierarchy of risk classification allows regulatory bodies to provide flexibility when reviewing medical devices.

Food and Drug Administration recognizes three classes of medical devices, based on the level of control necessary to assure safety and effectiveness. Class I devices are subject to the least regulatory control and are not intended to help support or sustain life or be substantially important in preventing impairment to human health, and may not present an unreasonable risk of illness or injury. Class II devices are subject to special labeling requirements, mandatory performance standards and postmarket surveillance.

Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury and require premarket approval. There are basically four classes, ranging from low risk to high risk.

Medical Device Regulatory Practices: An International Perspective

The authorization of medical devices is guaranteed by a Declaration of Conformity. A Notified Body is a public or private organisation that has been accredited to validate the compliance of the device to the European Directive. Medical devices that pertain to class I on condition they do not require sterilization or do not measure a function can be marketed purely by self-certification. The European classification depends on rules that involve the medical device's duration of body contact, invasive character, use of an energy source, effect on the central circulation or nervous system, diagnostic impact, or incorporation of a medicinal product.

Certified medical devices should have the CE mark on the packaging, insert leaflets, etc..

These packagings should also show harmonised pictograms and EN standardised logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, don't reuse, etc. In November the Federal Administrative Court of Switzerland decided that the "Sympto" app, used to analyze a woman's menstrual cycle, was a medical device because it calculates a fertility window for each woman using personal data.

The manufacturer, Sympto-Therm Foundation, argued that this was a didactic, not a medical process.

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Medical devices excluding in vitro diagnostics in Japan are classified into four classes based on risk: [21]. Classes I and II distinguish between extremely low and low risk devices. Classes III and IV, moderate and high risk respectively, are highly and specially controlled medical devices. In vitro diagnostics have three risk classifications.

For the remaining regions in the world the risk classifications are generally similar to the United States, European Union, and Japan or are a variant combining two or more of the three countries' risk classifications. Similarly to the EU classification, they rank in several categories, by order of increasing risk and associated required level of control.

Various rules identify the device's category [23]. The Medical Devices Bureau of Health Canada recognizes four classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Class I devices present the lowest potential risk and do not require a licence. Class II devices require the manufacturer's declaration of device safety and effectiveness, whereas Class III and IV devices present a greater potential risk and are subject to in-depth scrutiny.

Iran produces about 2, types of medical devices and medical supplies, such as appliances, dental supplies, disposable sterile medical items, laboratory machines, various biomaterials and dental implants. Some Iranian medical devices are produced according to the European Union standards. Some producers in Iran export medical devices and supplies which adhere to European Union standards to applicant countries, including 40 Asian and European countries.

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    Medical Device Regulatory Practices: An International Perspective Medical Device Regulatory Practices: An International Perspective
    Medical Device Regulatory Practices: An International Perspective Medical Device Regulatory Practices: An International Perspective
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