journal of biomedical informatics
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Reid Peter*
Department of Environmental Health Sciences, Columbia University, New York, USA, Email:
*Correspondence: Reid Peter, Department of Environmental Health Sciences, Columbia University, USA, Email:

Received: 31-Dec-2022, Manuscript No. 87433; Editor assigned: 02-Jan-2023, Pre QC No. 87433; Accepted Date: Dec 31, 2022 ; Reviewed: 16-Jan-2023 QC No. 87433; Revised: 19-Jan-2023, Manuscript No. 87433; Published: 20-Jan-2023, DOI: 10.24105/ejbi.2022.19.1.167-168

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Any object designed for use in medicine is considered a medical device. Utilizing a device for medical purposes carries a large risk of risks; hence medical devices must be demonstrated to be safe and effective with a fair degree of assurance before governing governments permit the sale of the device in their nation. In general, the quantity of testing needed to verify a device's safety and efficacy increases as the associated risk does. Additionally, if related risk rises, the patient's potential benefit must rise as well. In Baluchistan, where Neolithic dentists utilised flint-tipped drills and bowstrings, researchers discovered what would be regarded as medical equipment by contemporary standards as early as 7000 BC. Research into Roman medical writings and archaeology also suggests that a variety of medical gadgets were in common usage during the time of ancient Rome. Medical devices weren't governed in the United States until the Federal Food, Drug, and Cosmetic Act (FD&C Act) was passed in 1938. The Medical Device Amendments to the FD&C Act, which were passed later in 1976, established medical device regulation and oversight in the United States as we know it today. The legislation that established the current system of medical device regulation in Europe was passed in 1993 and is collectively known as (MDD). The MDD was replaced by the Medical Device Regulation (MDR) on May 26, 2017


Trocar, MAUDE database, Laparoscopy, Injury.


Both the intended application and the indications for usage of medical devices differ. Simple, low-risk examples include tongue depressors, medical thermometers, disposable gloves, and bedpans, whereas complex, high-risk examples include implantable devices that support life. The use of pacemakers and other embedded software-enabled devices for medical diagnostics, implants, and prosthetics is an example of a high-risk device. A significant area of the study of biomedical engineering is the design of medical equipment [1].

The market for medical devices was expected to be worth. In 2006, it was worth around US$209 billion. The world market is dominated by the United States, which holds around 40% of it, followed by Europe , Japan has the second-largest country market share, even though Europe as a whole has a greater share. Germany, Italy, France, and the United Kingdom hold the largest market shares in Europe (ordered by market share size). The rest of the world includes nations like Australia, Canada, China, India, and Iran, in no particular order [2]. The purpose of this article is to explore what defines a medical device in each of these regions. The regions are discussed in the article in order of their global economic importance [3].

Each Member State‘s government is required to designate a qualified organisation in charge of medical devices. The competent authority (CA) is a body with the power to act on behalf of the member state to make sure that the provisions of medical device directives are incorporated into national law and applied by the member state government. The member state‘s minister of health receives reports from the CA. Although the CA in one member state has no jurisdiction in any other member state, they do communicate and attempt to find common ground [4].

According to the Food and Drug Act, a „medical device“ is „anything created, sold, or advertised for use in identifying, treating, preventing, mitigating, or reducing a disease, disorder, abnormal physical state, or its symptoms in a person; restoring, correcting, or changing a body function or body structure in a person; identifying pregnancy in a person; or caring for a person while pregnant. There is no pill included, but there is a contraceptive method.“

The phrase refers to a broad range of health or medical devices used for the prevention, treatment, control, or diagnosis of a disease or other abnormal physical state. Before approving their sale in Canada, Health Canada analyses medical devices to determine their quality, effectiveness, and safety. The Act states that any item made with animal use in mind is not considered a medical device [5].

In Indian law, the word „medical devices“ is not specifically defined. However, under the Drugs & Cosmetics Act, a few medical gadgets are classified as DRUGS. Devices designed for internal or external use in the diagnosis, treatment, mitigation, or prevention of disease or disorder in humans or animals are also considered drugs of the definition of „drugs.“


The technology promises to create an antibacterial biomaterial whose activity is not constrained by rising antibiotic resistance and enables the first silver impregnation (as opposed to coating) of medicinal polymers.


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