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Encyclopedia > Medical device

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European Definition

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices defines a ‘medical device’ as:


any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

  • — diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • — diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • — investigation, replacement or modification of the anatomy or of a physiological process,
  • — control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the UK under European legislation. Medical devices must not be mistaken with medicinal products. The logo of the MHRA. The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe. ...


Definition in USA by the Food and Drug Administration

A medical 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: “FDA” redirects here. ... A modern hammer is directly descended from ancient hand tools A tool or device is a piece of equipment which typically provides a mechanical advantage in accomplishing a physical task, or provides an ability that is not naturally available to the user of a tool. ... This article is about devices that perform tasks. ... An implant is an artificial device made to replace and act as a missing biological structure. ... Wiktionary has a definition of: In vitro In vitro (Latin: within glass) means within a test tube, or, more generally, outside a living organism or cell. ... A reagent is a material used to start a {[chemical reaction]}. For example hydrochloric acid is the chemical reagent that would cause calcium carbonate to release carbon dioxide. ...

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of 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 any of its primary intended purposes.

as defined by the Federal Food, Drug, and Cosmetic Act, 21 United States Code [321] (h). A National Formulary is a manual containing a list of medicines that are approved for prescription throughout the country, indicating which products are interchangeable. ... The United States Pharmacopoeia is a compendium of drugs published every five years by the United States Pharmacopoeial Convention. ... In general, diagnosis (plural diagnoses) has two distinct dictionary definitions. ... This article is about the medical term. ... In medicine, prevention is any activity which reduces the burden of mortality or morbidity from disease. ... A few of the metabolic pathways in a cell. ... The United States Code (U.S.C.) is a compilation and codification of the general and permanent federal law of the United States. ...


Classification:

United States

The Food and Drug Administration has recognized three classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device.[1] The classification procedures are described in the Code of Federal Regulations, Title 21, part 820 (usually known as 21 CFR 820). The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations (sometimes called administrative law) published in the Federal Register by the executive departments and agencies of the Federal Government of the United States. ...


Class I: General Controls

Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. These devices are subject only to general controls. General controls cover such issues as manufacturer registration with the FDA, good manufacturing techniques, proper branding and labelling, notification of the FDA before marketing the device, and general reporting procedures.[2] (Most Class I devices are exempt from the good manufacturing practices and/or the FDA notification regulations.)[2] These controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device; or the device is not life-supporting or life-sustaining and does not present a reasonable source of injury through normal usage. Devices in this category include tongue depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical instruments and other similar types of common equipment. Injury is damage or harm caused to the structure or function of the body caused by an outside agent or force, which may be physical or chemical. ... A bedpan is a toileting facility, usually consisting of a metal, glass, or plastic receptacle for urinary and fecal discharge. ... Bandages are also used in martial arts to prevent dislocated joints. ...


Class II: General Controls with Special Controls

Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance.[2] Devices in Class II are held to a higher level of assurance than Class I devices that they will perform as indicated and will not cause injury or harm to patient or user. Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material, and acupuncture needles. The term non-invasive in Medicine has two meanings: A medical procedure which does not penetrates or breaks the skin or a body cavity, i. ... In the NATO phonetic alphabet, X-ray represents the letter X. An X-ray picture (radiograph) taken by Röntgen An X-ray is a form of electromagnetic radiation with a wavelength approximately in the range of 5 pm to 10 nanometers (corresponding to frequencies in the range 30 PHz... An image as stored on a picture archiving and communication system (PACS) The same image following contrast adjustment, sharpening and measurement tags added by the system In medical imaging, picture archiving and communication systems (PACS) are computers or networks dedicated to the storage, retrieval, distribution and presentation of images. ... This article does not cite any references or sources. ... An infusion pump or perfusor infuses fluids, medication or nutrients into a patients circulatory system. ... Acupuncture chart from Hua Shou (fl. ...


Class III: General Controls and Premarket Approval

A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices. Such a device needs premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. Class III devices are described as those for which "insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls ... would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury."[3]


Examples of Class III devices which require a premarket approval include replacement heart valves, silicone gel-filled breast implants, implanted cerebral stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants which were recently reclassified as Class II). It has been suggested that this article or section be merged with Heart valve prosthesis. ... Silicones (more accurately called polymerized siloxanes or polysiloxanes) are inorganic-organic polymers with the chemical formula [R2SiO]n, where R = organic groups such as methyl, ethyl, and phenyl. ... A breast implant is a prosthesis used to enlarge the size of a womans breasts (known as breast augmentation, breast enlargement, mammoplasty enlargement, augmentation mammoplasty or the common slang term boob job) for cosmetic reasons; to reconstruct the breast (e. ... A pacemaker, scale in centimeters A pacemaker (or artificial pacemaker, so as not to be confused with the hearts natural pacemaker) is a medical device which uses electrical impulses, delivered by electrodes contacting the heart muscles, to regulate the beating of the heart. ...


European Union and European Economic Area

The classification of medical devices in the European Union is outlined in Annex IX of DIR 93/42/EEC. There are basically four classes, ranging from low risk to high risk.  EFTA countries (except Switzerland)  EU countries Together these form the EEA. The European Economic Area (EEA) came into being on January 1, 1994 following an agreement between the European Free Trade Association (EFTA) and the European Union (EU). ...


Class I
Class IIa
Class IIb
Class III


The authorisation of medical devices is guaranteed by a Certificate of Conformity. This certificate is issued by the manufacturer itself, but for products in classe II until III, it should be backed by a so-called Notified Body, i.e. a test organisation accredited to validate the compliance of the device to the European Directive. Medical devices that pertain to class I (on condition they do not need to be sterilised or are not used to measure a function) can be put on the market purely by self-certification.


The European classification depends on rules that involve the medical device's duration of body contact, its invasive character, its use of an energy source, its effect on the central circulation or nervous system, its diagnostic impact or its 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 ISO standardised logo's to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, don't reuse, etc... The constructional details of CE mark The CE mark (officially CE marking) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). ... ISO has many meanings: Iso is the stem of the Latin transliteration of the Greek word ίσος (ísos, meaning equal). The iso- prefix in English derives from this and means equality or similarity. ...


Notes and References

  1. ^ FDA website: Classify your Medical Device
  2. ^ FDA Device Classification
  3. ^ Title 21 Food and Drugs Subchapter-H Medical Devices

Medical Device Regulatory and Certification Providers

The UL Mark Underwriters Laboratories Inc. ...

Medical device companies

Abbott Laboratories (NYSE: ABT) is a diversified pharmaceuticals and health care company. ... Baxter International Inc. ... BD (NYSE: BDX) — originally, Becton & Dickinson — is a leading global medical technology company that manufactures and sells medical devices, instrument systems and reagents. ... The Boston Scientific Corporation (NYSE: BSX) (abbreviated BSC), is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a range of interventional medical specialties, including interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynecology. ... C. R. Bard, Inc. ... Conceptus, which is headquartered in Mountain View, California, was founded in 1992. ... The Cook Group, founded in 1963 in the spare bedroom of William and Gayle Cook, is a supplier of medical devices and equipment. ... Edwards Lifesciences (NYSE: EW) is a global leader in products and technologies to treat advanced cardiovascular disease, the global leader in acute hemodynamic monitoring and the number-one heart valve company in the world. ... Endotec Inc. ... GE Healthcare is a $14 billion (USD) unit of General Electric. ... Hospira, Inc. ... Johnson & Johnson (NYSE: JNJ) is a global American pharmaceutical, medical devices and consumer packaged goods manufacturer founded in 1886. ... Medtronic, Inc. ... Mindray Medical International Limited (NYSE: MR) is Chinas largest medical equipment manufacturer[1], developing and marketing Patient Monitoring Systems, Ultrasound Systems, Anesthesia Delivery Systems, Laboratory Analyzers, and Veterinary Equipment. ... Philips HQ in Amsterdam Koninklijke Philips Electronics N.V. (Royal Philips Electronics N.V.), usually known as Philips, (Euronext: PHIA, NYSE: PHG) is one of the largest electronics companies in the world, founded and headquartered in the Netherlands. ... Phonak is a Swiss company that specializes in wireless and hearing systems. ... Siemens Medical Solutions (Siemens Med) is a supplier to the healthcare industry headquartered in Erlangen, Germany and Malvern, Pennsylvania. ... Smith & Nephew is a British medical devices company headquartered in London and active internationally. ... Spacelabs redirects here. ... St. ... Stryker Corporation (NYSE: SYK) develops, manufactures and markets specialty surgical and medical products for the global market. ... Tyco Healthcare is the healthcare division of Tyco International, due to be split off in 2007. ... Unitron is a manufacturer of optical instruments including microscopes, binoculars, and formerly telescopes. ... Vital signs are often taken by health professionals in order to assess the most basic body functions. ... A Zimmer Frame is the trademarked name for a supportive frame designed to assist the elderly or disabled. ...

See also

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. ... To meet Wikipedias quality standards, this article or section may require cleanup. ... The AbioCor artificial heart, an example of a biomedical engineering application of mechanical engineering with biocompatible materials for Cardiothoracic Surgery using an artificial organ. ... A Biomedical Equipment Technician (BMET) is a vital component of the healthcare delivery system. ... A Clinical engineer is a professional who supports and advances patient care by applying engineering and managerial skills to healthcare technology. ... This is a term of art used to describe certain Medicare benefits, that is, whether Medicare may pay for the item. ... This article discusses the definitions and types of home medical equipment (HME), also known as durable medical equipment (DME), prosthetics and orthotics (DMEPOS). ... This article does not cite any references or sources. ... A mobility scooter is a mobility aid similar to a wheelchair but configured like a motorscooter. ... Wheelchair seating A wheelchair is a device used for mobility by people for whom walking is difficult or impossible, due to illness or disability. ... The Global Harmonization Task Force (GHTF) is “a voluntary group of representatives from national medical device regulatory authorities (such as the FDA) and the members of the medical device industry”[1] who’s goal is the standardization of medical device regulation across the world. ...

External links


  Results from FactBites:
 
Medical device - Wikipedia, the free encyclopedia (705 words)
These controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device; or the device is not life-supporting or life-sustaining and does not present a reasonable source of injury through normal usage.
Devices in Class II are held to a higher level of assurance than Class I devices that they will perform as indicated and will not cause injury or harm to patient or user.
Examples of Class III devices which require a premarket approval include replacement heart valves, silicone gel-filled breast implants, implanted cerebellar stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants which were recently reclassified as Class II).
Food and Drug Branch - Medical Device Safety Program (2137 words)
While the focus of medical device regulation in California has changed somewhat with the evolution of the federal program, the state works in partnership with the FDA to coordinate its activities, avoid duplication, and work toward a "seamless" regulatory environment in California.
Under these statutes, it is unlawful to sell, deliver, or give away drugs or medical devices that are not generally recognized among experts as being safe and effective for their intended use unless it is done under certain controlled conditions.
Medical device manufacturers within the state must be licensed, and a separate license must be obtained for each place of manufacture.
  More results at FactBites »

 
 

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