Medical Devices

Regulations, Standards and Practices

Seeram Ramakrishna, Lingling Tian, Charlene Wang, Susan Liao, Wee Eong Teo

• Publisher: Woodhead Publishing
• Year: 2015
• ISBN:
  9780081002919
• Topic: Medicine
• Subtopic: Medical Technology & Supplies

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices.

Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards.

• Provides readers with a global perspective on medical device regulations
• Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards
• Includes a useful case study demonstrating the design and approval process

1

Introduction

1.1 Medical devices: definitions and types

Definitions of medical devices have been summarized in Table 1.1 [1–4]. Although they are slightly different, main descriptions of medical devices are generally similar. Other than drugs, medical-related instruments, apparatuses, implements, machines, appliances, implants, in vitro reagents or calibrators, software, materials or other similarly related articles are considered medical devices.

Table 1.1

Definition of medical device

Organization	Definition	Type	Resource and issue date	Remarks
US FDA	“An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: • 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 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” [1].	Class I, II, & III	In section 201(h) by Federal Food, Drugs, and Cosmetic Act (FD&C), 2006 Edition, Supplement 3 current through January 5, 2010.	The definition provides a clear distinction between a medical device and other FDA regulated products such as drugs.
WHO GHTF SGI	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 human beings, for one or more of the specific medical purpose(s) of: • diagnosis, prevention, monitoring, treatment or alleviation of disease, • diagnosis, monitoring, treatment, alleviation of or compensation for an injury, • investigation, replacement, modification, or support of the anatomy or of a physiological process. • supporting or sustaining life, • control of conception, • disinfection of medical devices, • providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means [2].		revision of GHTF/SG1/N29:2005, May 16, 2012	Products which may be considered to be medical devices in some jurisdictions but not in others include: disinfection substances, aids for persons with disabilities, devices incorporating animal and/or human tissues, devices for in vitro fertilization or assisted reproduction technologies.
EU	Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and 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 This includes devices that do not achieve their principal intended action in or on the human body by pharmacological, immunological, or metabolic means—but may be assisted in their function by such means [3].	Class I, IIa, IIb, and III	Directive 2007/47/EC, 5 September 2007
ISO 13485	any instrument, apparatus, implement, 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 i...