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Expanding the understanding of the classification system described by the European Medical Devices Directive: New guidance document published by Global Regulatory Press

London, 5 October 2009 – Global Regulatory Press has published a guidance document entitled 'Principles and Practice of Medical Device Classification'.

The guidance document presents an introduction to the principles and practice of classification of medical devices. It expands education on the classification system described by the European Medical Devices Directive, introducing the reader to the fundamentals of classification, in an attempt to explore the origin, design, construction and practice of the scheme according to the theory and practice of classification.

According to the guidance document’s author, Mr Haroon Atchia, 'The prospect of writing any kind of text to examine the principles of classification and application to regulation of medical devices was conceived originally to offer the analytically-literate regulatory assurance professional an introduction to the reasons for classification of such products around the world, compare and contrast the various extant schemes, and to investigate similarities and dis-similarities in an attempt to promote understanding of how such schemes were devised, are constructed and applied. As the report developed, it transpired that the most widely used classification schemes fail to adhere to the fundamental principles of the discipline; in fact, they suffer from some basic flaws. It is hoped, therefore, that this guidance document conveys the importance of analysis and thorough, scientific re-appraisal of some of the prevailing schemes or, if not this, then that it serves as a useful reference for design of future classification schemes for medical devices.'

This guidance document is suitable for manufacturing personnel needing an introduction to European product classification, specialists performing or assessing classification, and regulatory specialists in manufacturers and regulatory authorities.

A large, detailed flowchart depicting the product classification process according to Annex IX to Council Directive 93/42/EEC (as amended) is also included.

Specification: 121 pages plus covers, plus accompanying flowchart, in English, supplied by email as a PDF. Price: £175 (plus VAT, where applicable). ISBN-13: 978-1-903757-05-5.

About Global Regulatory Press

Global Regulatory Press is the London-based publisher of the Journal of Medical Device Regulation (JMDR). The JMDR is intended to educate, provide professional guidance, develop core competence of regulatory professionals, and promote debate on fundamental and topical matters within the medical device industry. In addition to publishing review and discussion articles by opinion leaders from the device community, the Journal summarises the news headlines from around the world and provides useful reference information in the form of charts and briefing documents. The Journal is a quarterly, subscription-only publication which is currently only available in electronic format. Full articles are only accessible to subscribers of the JMDR.

For Further Information

For more information on Global Regulatory Press or the JMDR, please contact Marija Capek (tel: +49 (0)621 166 23 26) or visit the Global Regulatory Press website at  www.globalregulatorypress.com.

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