Classification of medical devices

The term medical device covers a vast range of equipment and materials, from simple tongue depressors to hemodialysis machines. Like medicines and other health technologies, they are essential for patient care, for example, at the bedside, in a rural health clinic, or in large, specialized hospitals. 

The GHTF has proposed a harmonized definition for medical devices, which means any instrument, apparatus, implanent, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of  

It is noted that an accessory is not considered to be a medical device. However, where an accessory is intended specifically by its manufacturer to be used together with a parent medical device to enable the device to achieve its intended purpose, it should be subjected to the same procedures and GHTF guidance documents as applied to the medical device itself. 

It should also be noted that the definition of a device for in vitro examination includes, for example, reagents, calibrators, sample collection devices, control materials, and 

Some products are considered to be medical devices in some jurisdictions, but there is not as yet a harmonized approach for these items. Examples include aids for disabled or handicapped people, devices for the treattnent or diagnosis of diseases and injuries in animals, spare parts for medical devices, and devices incorporating animal and human tissues which may meet the requirements of the above definition but are subjected to different controls. 

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Figure 9.5 Relationship between risk and classification of medical devices.

Table la Classifications of medical devices marketed in the united states... 

Table lb Classifications of medical devices of the european union ... 

European Commission. Medical device guidance document. Classification of medical devices. Guidehnes relating to the application of the Council Directive 93/42/EEC on Medical Devices. 2010. 

Classifications of Medical Device Accidents and Medical Device Accident Occurrence Probability Estimation... 

List seven main classifications of medical device accidents. 

Classification of medical devices is related to the operational complexity degree of the equipment, the cost and time needed for training the health professional. According to Calil and Teixeira [5] this complexity can be (a) low-easy operation, no need for skilled human resource and training (b) medium-requires human resources with basic formation and equipment proper training and (c) high-demands qualified and specialized technicians and specific training. 

A definition or classification of medical device failure is missing. 

Health Canada (2009) Classification of medical devices Class I or Class II patient management software. Health Canada notice file number 09-122095-269. http //www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/md notice software im avis logicels-eng.php. Accessed 17 September 2009... 

Initial consideration of these factors gives a basis for further classification (which can be made by the manufacturer himself) and also determines the relevant conformity assessment procedure that must be followed by the manufacturer. Table 9.4 presents the classification of medical devices according to the European regulation— Directive 93/42/ECC (European Commission, 2012). 

Table 9.5 Classification of medical devices in the United States...

The previous chapter outlined how device classification and the use of standards provide the basis for effective regulation of medical devices, with particular focus on the application of design control standards to the development of devices. In this chapter we look at the process for evaluation and authorisation of devices, and see how the regulatory requirements vary depending on the perceived risk of the device as indicated by its classification. It will be noted that there is considerable variation between the approaches adopted in Europe and the US and that, compared to dmgs, practical harmonisation of requirements still remains to be adopted. 

Revision of medical device regulations has occurred in other countries, including Canada and the United States, because of the European experience. In 1998, Canada changed its device regulations to include a risk-based classification system and 11 principles of safety and effectiveness, which were patterned after the essential requirements of the European MDD (22). 

Class I refers to what level of medical device classification ... 

European Commission. Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices. 2012. Report No. MEDDEV 2.1/6. 

The European Union (EU) attempted a more standardized and rational approach to the classification and regulation of medical devices along broad risk-based categories. Canada and Australia have used a similar approach in their regulation of medical devices. To determine how a new product is regulated in the EU system, an individual first determines classification based upon certain rules . These rules are illustrated in a flow chart which can be read to determine how a device may be regulated, more or less independently of the details of construction or materials. 

This topic first contextualizes the medical devices as well as their definition, function and classification, and then addresses the process of developing new products targeted for medical area and its evolution/innovation. At the end, it is presented the importance of CE philosophy in the integrated development process of medical devices. 

There is a huge variety of medical devices. The range and depth of medical devices (and medical textiles) can be appreciated from Table 12.1, where the FDA classificafimi of medical devices into speciality Device Classification Panels such as Cardiovascular... 

At the end of this life cycle, a medical device must be properly disposed following the indications of the manufacturer and the regulatory classification. In fact, an incorrect disposal of medical device could result in injury for the personnel that handle the device during the disposal operations. For example, scaffolds that have been treated with human cells or tissues can be a source of infective viruses or bacteria for the operators and the environment. 

In the FDA regulatory classifications there are three classes of medical devices Class I, Class II, and Class III. This classification is based upon classifications for medical devices currently legally marketed in the United States. The FDA determines the device classification by the device s intended use and the risk that it presents to the patient. New medical devices are compared to legally marketed medical devices with the same intended use and technological characteristics to determine the classification. 

Unlike Europe, all the aspects of registration and market approval of medical devices in the United States are under the responsibility of a single and centralized body the Center for Devices and Radiological Health (CDRH) of the FDA. The FDA assigns medical devices to one of three regnlatory classes (Classes I, II, and III) based on their intended use, whether the device is invasive or implantable, and the risk posed by the device to the user. Regulatory control increases from Class I to Class III and the manufacturer can nse the FDA s classification database to determine the classification of the medical device. As presented in Table 9.5, and... 

Color Additives. The FDA has created a unique classification and strict limitations on color additives (see also CoLORANTS FOR FOOD, DRUGS, COSMETICS, AND MEDICAL DEVICES). Certified color additives are synthetic organic dyes that ate described in an approved color additive petition. Each manufactured lot of a certified dye must be analyzed and certified by the EDA prior to usage. Color lakes are pigments (qv) that consist of an insoluble metallic salt of a certified color additive deposited on an inert substrate. Lakes are subject to the color additive regulations of the EDA and must be certified by EDA prior to use. Noncertifted color additives requite an approved color additive petition, but individual batches need not be EDA certified prior to use. 

Medical devices are regulated on the basis of a three-level risk classification. The highest risk products are the class 3 products that require premarket applications, almost always with clinical data that demonstrate that the product is safe and effective for the intended use. By default, a novel product is a class 3 product unless there is an approval application for initial approval as a class 2 device (the de novo process). Clinical trials for class 3 products before they are approved usually require an IDE, which is similar to the IND required for investigational drugs. 

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