Journal of Medical Device Regulation - Bookstore

Essential Principles of Safety & Efficacy: Streamlining design and documentation processes for global compliance of medical devices (September 2009)

Price: £49.99 (plus VAT, where applicable*)

A well-structured technical documentation with full traceability to all applicable Essential Requirements significantly shortens the preparation time for submissions in all major markets and is extremely useful during quality systems' audits by health authorities. By aligning a product's technical documentation with the regulations in Europe, the USA, Canada and Australia from the outset, registrations can be submitted to these and other countries in parallel, without the need to re-do the technical documentation each time. It is essentially like creating 'one size fits all' design and manufacturing documentation for all major markets.

Following an introduction about the traditional approach to preparing documentation and a suggested smarter approach, this document compares, in tabular form, the Essential Requirements for Europe, Canada and Australia, as well as the GHTF principles of safety and efficacy. The US regulatory framework for medical devices is different from that of the European Union/Canada/Australia, in that the US Food and Drug Administration does not define generic essential requirements for safety and effectiveness, but rather issues guidance documents that are specific to various categories of medical devices. The elements that must be covered align a great deal with the Essential Requirements defined in the European/Canadian/Australian regulations and the GHTF Essential Principles, and are also included in the chart.

Specification: 85 pages plus covers, in English, supplied by email as a PDF.
This document was published as a supplement to the February 2009 edition of the Journal of Medical Device Regulation.

Principles and Practice of Medical Device Classification (August 2009)

Price: £175 (plus VAT, where applicable*)

This guidance document presents an introduction to the principles and practice of classification of medical devices, and has been specially developed for all levels of personnel involved in the design, manufacture and regulation of medical devices falling under Directive 93/42/EEC. The guidance expands the reader's understanding of the classification system described by the Medical Devices Directive by explaining 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.

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

Click here to read the table of contents for this publication.

Specification: 121 pages plus covers, plus accompanying flowchart, in English, supplied by email as a PDF.
ISBN-13: 978-1-903757-05-5

Medical Device Regulations in the Americas (March 2009)

Price: £165 (plus VAT, where applicable*)

This fourth and final part of the Journal of Medical Device Regulation's series of Special Editions on international medical device registration requirements provides an overview of the national registration requirements in the Americas.

This edition covers: the Latin American region in general, Argentina, Brazil, Canada, Colombia, Costa Rica, Cuba, Mexico, Uruguay, the USA and Venezuela.

Topics covered for each country include, where appropriate, the regulatory authority, the legal framework, the regulatory controls in place for medical devices, standards information, vigilance and post-market surveillance requirements, labelling and language requirements and likely future developments.

Specification: 70 pages plus covers, in English, supplied by email as a PDF.
ISBN-13: 978-1-903757-04-8

Buy all four Special Editions and receive a 10% discount on your total bill.
Email marija@globalregulatorypress.com for full details.

The US FDA PMA Filing and Approval Experience (November 2008)

Price: £49.99 (plus VAT, where applicable*)

This three-part publication examines various aspects of the US Food and Drug Administration (FDA) premarket approval application (PMA) process, which is the regulatory pathway for the introduction of Class III medical devices into commercial distribution in the USA.

Part one is devoted to performing a descriptive and statistical analysis of the PMA process based on information contained in the FDA PMA database for PMA applications from the years 2003 through 2007 inclusive.

Part two is devoted to performing a descriptive and statistical analysis comparing the PMA process to the European Union CE marking approval process in an effort to identify the potentially superior system.

Part three describes and analyses the reasons why, historically, US PMA applications have been found to be not approvable by the FDA. The research found that from December 2002 through to the time that the research was conducted in 2007, there were seven PMA applications that were disapproved by the FDA based in part on disapproval recommendations by the FDA appointed scientific Advisory Panels. Of these seven PMA applications, five of the devices were found to have received prior European CE marking.

These three articles have previously been published in the November 2007, February 2008 and August 2008 issues of the Journal of Medical Device Regulation, respectively.

Specification: 49 pages plus covers, in English, supplied by email as a PDF.

Guidance on the Essential Requirements of the European Medical Devices Directive (MDD) (August 2008)

Price: £175 (plus VAT, where applicable*)

When the 'New Approach' Directives were implemented, they brought with them a fresh outlook on the instruments that can be used in the regulation of medical devices. Among the interesting and unique features of the European Directives is the concept of reducing device commonality to core elements, termed Essential Requirements. These Essential Requirements serve as the foundation for achieving conformity with the Directives and devices that satisfy them become entitled to bear the CE mark.

Essential Requirements are present in each of the three core Directives developed for medical devices. They share considerable identity in objective, appearance and content, yet vary in definite areas that reflect the technological characteristics of the medical device portfolios covered by the individual Directives.

This publication examines the nature of Essential Requirements, and how they are identified and defined, relating the use in the European regulatory domain to the practical issues surrounding Declaration of Conformity. The Essential Requirements of Directive 93/42/EEC are studied one by one, with suggestions being made about practical approaches for ensuring correct identification, use, accommodation and fulfilment of the Essential Requirements, highlighting typical difficulties and recommending solutions.

Specification: 74 pages plus covers, in English, supplied by email as a PDF.

Medical Device Regulatory Requirements in China and Hong Kong (June 2008)

Price: £29.99 (plus VAT, where applicable*)

The Chinese medical devices market is one of the largest in the world and was worth over US$3.7 billion in 2007. China's regulatory system for medical devices is still in its development phase, which inevitably leads to a certain degree of confusion and ambiguity. This report helps to clarify matters by describing the Chinese SFDA's organisational structure, the legal basis for the regulations, the definition of a medical device, the classification system, information on standards, the registration process, post-market surveillance, and the restrictions on the use of hazardous substances.

Hong Kong imports virtually all of its medical products. It is a US$800 million medical equipment import market, with US imports claiming a 26% market share. This report describes the implementation of the Hong Kong Medical Devices Administrative Control System (MDACS), the labelling requirements, additional requirements, conformity assessment, suggested voluntary registration routes and likely future developments.

The information presented in this report was originally published in the Journal of Medical Device Regulation, 2007, 4(1), 3-20. It has been updated by Jack Wong, Vice President, Regulatory Affairs, Asia and General Manager, British Standards Institution, Hong Kong.

Specification: 8 pages plus covers, in English, supplied by email as a PDF.

Medical Device Regulations in Europe (Countries N to Z) (April 2008)

Price: £165.00 (plus VAT, where applicable*)

This third part of the Journal of Medical Device Regulation's series of Special Editions on international medical device registration requirements, provides an overview of the national registration requirements in Europe (countries N to Z).

This edition covers: the Netherlands, Norway, Poland, Portugal, Romania, Serbia, the Slovak Republic, Slovenia, Spain, Sweden, Switzerland and the UK.

Topics covered for each country include, where appropriate, the regulatory authority, the legislative framework, the regulatory controls in place for medical devices, standards information, vigilance and post-market surveillance requirements, labelling and language requirements and likely future developments.

Specification: 49 pages plus covers, in English, supplied by email as a PDF.
ISBN-13: 978-1-903757-03-1

Medical Device Regulatory Requirements in Iran (February 2008)

Price: £49.99 (plus VAT, where applicable*)

This publication provides a market profile of Iran as well as details of the country's regulatory authority and standards organisation. It then lists Iran's mandatory medical device related standards.

Iran is in the process of developing a specific medical device regulation and the preliminary draft text is summarised under the following headings:

• definition of a medical device;
• definition of a manufacturer;
• safety of medical devices;
• domestic production;
• importation;
• after-sales service;
• exportation;
• distribution and pricing;
• advertising, recall and trade shows;
• general considerations and requirements.

Also, in August 2007, a regulation came into force in Iran to control the illegal marketing of medical devices. The content of this regulation is also discussed in detail in this publication.

Specification: 10 pages plus covers, in English, supplied by email as a PDF.

Medical Device Regulations in Europe (Countries A to M) (November 2007)

Price: £165.00 (plus VAT, where applicable*)

This second part of the Journal of Medical Device Regulation's series of Special Editions on international medical device registration requirements, provides an overview of the national registration requirements in Europe (countries A to M).

This edition covers 21 countries in Europe: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg and Malta.

Topics covered for each country include, where appropriate, the regulatory authority, the legislative framework, the regulatory controls in place for medical devices, standards information, vigilance and post-market surveillance requirements, labelling and language requirements and likely future developments.

Specification: 50 pages plus covers, in English, supplied by email as a PDF.
ISBN-13: 978-1-903757-02-4

Reimbursement of Medical Devices in France, Germany, Italy, Spain & the United Kingdom (October 2007)

Price: £64.99 (plus VAT, where applicable*)

Receiving marketing authorisation or clearance does not guarantee reimbursement coverage for your medical device.

The Journal of Medical Device Regulation's new guide to the reimbursement of medical devices in France, Germany, Italy, Spain and the UK explains the coverage, coding and payment issues affecting each of these countries, with specialist input from:

• Robert Handschuh, Directeur Médical, Diomedes, France;
• Dr Thomas Seeger, Managing Director, Medalliance GmbH, Auggen, Germany;
• Maria Pia Pellegrino, Business & Regulatory Affairs Consultant, Italy;
• Martin Jordan, Managing Director, Health Technology Solutions (Spain) s.l., Barcelona, Spain;
• Carolyn Semple Piggot, Programme Director, Translucency Ltd, Worcester, UK.

Specification: 17 pages plus cover, in English, supplied by email as a PDF.

Key Revisions to the European Medical Device Directive, 93/42/EEC (August 2007)

Price: £129.99 (plus VAT, where applicable*)

Since its adoption in 1993, a great deal of experience has been gained on the implementation of Directive 93/42/EEC (the Medical Device Directive, MDD). Overall, the experience has been extremely positive, although some experience has revealed that the Directive requires improved implementation by all parties concerned. In order to support this improved implementation, legislative amendment was considered necessary both to clarify certain existing requirements and to provide a legal basis for planned initiatives.

This document summarises the important changes that have been made to the MDD, with particular reference to:

• the definition of a medical device;
• clinical evaluation;
• Notified Bodies and conformity assessment;
• classification;
• drug/device combination products;
• vigilance and post-market surveillance;
• risk analysis and risk management.

It also includes a marked-up version of Directive 93/42/EEC indicating the revisions to the Directive as at its first reading in the European Parliament.

Specification: 86 pages plus cover, in English, supplied by email as a PDF.

Medical Device Regulations in Asia, Africa and the Middle East (April 2007)

Price: £165 (plus VAT, where applicable*)

During 2007/8, the Journal of Medical Device Regulation will be publishing a series of Special Editions on international medical device registration requirements, which will provide an overview of the national registration requirements in Europe, Asia, Africa, the Middle East and the Americas.

This first edition covers 23 countries in Asia, Africa and the Middle East: Australia, China, Egypt, Hong Kong, India, Indonesia, Iraq, Japan, Kenya, Korean Republic (South), Malaysia, New Zealand, Pakistan, Philippines, Russian Federation, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Turkey, Ukraine and Vietnam.

Topics covered for each country include, where appropriate, the regulatory authority, the legislative framework, the regulatory controls in place for medical devices, standards information, vigilance and post-market surveillance requirements, labelling and language requirements and likely future developments.

Specification: 62 pages plus cover, in English, supplied by email as a PDF.
ISBN-13: 978-1-903757-01-7

A Beginners' Guide to the European Medical Devices Directive (MDD) (February 2007)

Price: £49.99 (plus VAT, where applicable*)

This white paper introduces the European system of 'New Approach' Directives for medical device regulation and describes the role of the Competent Authority, the manufacturer, and the Notified Body in this system. It then focuses on the MDD, Directive 93/42/EEC, by discussing its layout and structure, and how a manufacturer should conform to its requirements. Topics covered include:

• classification;
• Conformity Assessment Procedures;
• quality systems;
• the Essential Requirements;
• the use of European standards for demonstrating conformity;
• risk assessment or hazard evaluation;
• the technical documentation;
• clinical evaluation;
• declaration of conformity;
• vigilance and post-market surveillance;
• applying the CE mark;
• combination products;
• proposed amendments to the MDD;
• environmental factors (e.g. WEEE and RoHS); and
• frequently asked questions on the MDD.

Specification: 12 pages plus cover, in English, supplied by email as a PDF.

A Summary of WEEE Legislation and Compliance in the EU Member States (November 2006)

Price: £49.99 (plus VAT, where applicable*)

This booklet provides a tabulated summary of the Waste Electrical and Electronic Equipment (WEEE) legislation, registration requirements, financing, historical requirements, individual compliance and collective compliance requirements in each of the EU Member States.

Specification: 13 pages, in English, supplied by email as a PDF.

Meldewesen & Vigilanz - Pflichten der EU Autorisierten Repräsentanten in Deutschland, Frankreich und im Vereinigten Königreich (August 2006)

Price: £49.99 (plus VAT, where applicable*)

Artikel 10 der MDD beschreibt einen ziemlich allgemeinen Ansatz darüber, wie und von wem die Meldung von Vorkommnissen gehandhabt werden sollte. Die Direktive überlässt es den EU-Mitgliedstaaten, nationale Melde- und Überwachungsnormen sowie Verantwortlichkeiten zu erarbeiten. In diesem Artikel beschreibt Marija Capek die nationalen Melde- und Überwachungsvorschriften in Deutschland, Frankreich und im Vereinigten Königreich, skizziert die Verantwortlichkeiten der EU Autorisierten Repräsentanten und stellt wichtige Unterschiede zwischen den nationalen Anforderungen dieser Länder heraus.

Specification: 10 pages, in German, supplied by email as a PDF.