BIP 0113:2012 Guide to European Medical Device Trials and BS EN ISO 14155

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BIP 0113:2012

Guide to European medical device trials and BS EN ISO 14155

Status : Current   Published : June 2012



Guide to European Medical Device Trials and BS EN ISO 14155

Guide to European Medical Device Trials and BS EN ISO 14155 explains, in clear terms, how to comply with BS EN ISO 14155:2011, which was formed by the revision and merging of BS EN ISO 14155:2009, Parts 1 and 2. It highlights the differences between the old standards and the new one and how BS EN ISO 14155 relates to other standards, directives and guidance documents for medical devices.

Guide to European Medical Device Trials and BS EN ISO 14155 describes in detail the regulations, directives and standards governing medical devices and clinical trials, including Directives 93/42/EEC and 2007/47/EC, and MEDDEV 2.7.1 Rev. 3, as well as documenting the major changes introduced by BS EN ISO 14155:2011. Following this, it describes the process of initiating, conducting and reporting on a clinical investigation, with supporting industry examples of where problems can arise. It provides an invaluable reference as to how clinical trials of medical devices should be conducted.

It is a priceless guide for new researchers and a worthy reference source for experienced researchers, whilst providing an insight into the area of clinical trials for anyone involved in the production or marketing of medical devices.

About the Author
Duncan Fatz is an independent healthcare consultant and writer specializing in medical devices. As a clinical trials co-ordinator for the UK's North West Thames Health Authority, a researcher for the Medical Research Council and independent consultant and lecturer,
Duncan has been guiding medical device companies and their products through the clinical trial process and on to subsequent reimbursement approval in the major European markets for almost 20 years. He has written two reports on conducting medical device clinical trials for PJB Publications, and two courses for Informa Healthcare.


Standard NumberBIP 0113:2012
TitleGuide to European medical device trials and BS EN ISO 14155
Publication Date13 June 2012
Cross References2001/83/EC, BS EN ISO 14155:2011, EN ISO 25539-1:2009, EN ISO 25539-2:2009, EN ISO 10993, EN ISO 14630:2009, BS EN ISO 14971:2009, ISO 15223-1, EN 980:2008, GHTF/SG5/N3:2010, GHTF SG5 N2R8:2007, MEDDEV 2.1/3 Rev. 3, MEDDEV 2.7.1 Rev. 3, MEDDEV 2.4/1 Rev. 9 June 2010, MEDDEV 2.7.2, MEDDEV 2.7.3, MEDDEV 2.7.4, MEDDEV 2.12-1 Rev. 7, Jan. 2012, MEDDEV 2.12-2 Rev. 1, Jan. 2012
DescriptorsMedical equipment, Clinical testing, People, Clinical investigation instruments, Diagnosis (medical), Documents, Patients, Safety measures, Performance, Performance testing, Equipment safety, Risk assessment, Experimental data, Research methods
ISBN978 0 580 66436 6
File Size1.884 MB

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