RAJ Devices Back Issues
Please follow the links below to view details of back issues of RAJ Devices.
For information on larger quantities of customised articles visit out reprints page. For details of articles dating back further than 2003 and to order individuals
back issues, please contact us.
Jul/Aug 2004 (Vol 12 No 4)
Features
Interview with the UK MHRA - Kent Woods, chief executive of the UK Medicines and Healthcare products Regulatory
Agency, talks to RAI about challenges facing the new agency.
Japan Prepares New Regulatory System for Devices - Ed Rozynski explains how the Pharmaceuticals and Medical Devices Agency will
regulate medical devices from April 2005.
Interview with the US FDA - Mark Kramer, head of the FDA's Office of Combination Products, speaks with
RAJ about a proposal to define primary mode of action.
Meeting report - Joanne Beesley discusses the development of an EU-wide regulatory framework
for human tissue-engineered products.
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May/Jun 2004 (Vol 12 No 3)
Features
Guest Editorial - Kristen Giovanis promotes the cause of e-labelling in Europe.
RAJ Briefing - Philip Greenfield explains some of the changes that are taking place in the
electromedical sector.
Conference Report - Maureen Kenny reports on the FDA's views on the development and application
of standards.
Reporting Adverse Incidents and Dealing with Competent Authorities - Petri Pommelin says medical device vigilance guidelines must be better implemented.
User Fees are Transforming Device Regulation - Karen Riley reports from the AdvaMed annual meeting.
EU Accession and the Medical Device Sector - Joanne Beesley provides essential information for device companies as the EU
expands to 25 member states.
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Mar/Apr 2004 (Vol 12 No 2)
Features
Guest Editorial:
The De Novo 510(k) Process: How to Down-Classify Novel Devices from Class III
- Kristen Zielinski and Kelliann Harrison Payne explain the route for reclassifying
devices initially categorised as high-risk in the US.
Medical Device Regulation: A Model Framework - World Health Organization guidance is aimed at helping countries with limited
infrastructure build an effective regulatory system.
Designing Medical Devices and IVDs for Today's World - Sue Spencer looks at the role of quality systems in design control in the EU.
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Jan/Feb 2004 (Vol 12 No 1)
Features
Guest Editorial - Steve Owen comments on the EU Notified Body Operations Group handbook.
The Argument for a European Medical Device Agency - A new book by Sharon Frank looks at the shortcomings of the regulatory system
for devices in Europe.
Global Medical Device Nomenclature - An Idea Whose Time Has Come - Maurice Freeman outlines the progress made in introducing a global naming system.
How to Run an Efficient Vigilance and Post-Market Surveillance System in Europe
- RAJ reports on a recent London training course for medical device regulatory
affairs professionals.
Breast Implants in the US - A Compelling Case Study in FDA Regulation - Karen Riley looks back on 12 years of controversy.
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Nov / Dec 2003 ( Vol 11 No 6)
Features
Guest Editorials:
Magnetic Resonance Imaging - RAJ reports on the Nobel Prize.
European Industry proposes E-Labelling for Devices - RAJ reports on a debate in the EU over proposals to provide health professionals
with information on device use electronically.
Joint Replacements - Will They be Reclassified in Europe or not? - Maureen Kenny reports on industry's opposition to a European Commission proposal.
Plans Take Shape To Make Device Evaluation System More Transparent for Consumers
- RAJ reports on an initiative to provide the public in Europe with more information
on devices.
Implementing EU Medical Device Legislation in the Accession Countries - Eucomed reports on transposition of EU law in the prospective member states.
Europe Prepares To Chair the GHTF - RAJ reports on likely changes to the global harmonisation initiative.
Corrections and Removals - Is 21 CFR 806 the Forgotten Regulation? - Robert Titkemeyer and Diane Mandell explain the importance of the US rule.
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Sept / Oct 2003 ( Vol 11 No 5 )
Features
ISO 13485:2003 - The Emerging Global Requirement for Quality Systems - Paul Brooks of BSI reports on the new quality system standard.
Achieving Compliance with ISO 14155-1:2003 - Gordon Crowley examines the new standard for clinical investigations.
Conducting Medical Device Trials in the European Union - A new guide leads companies through the regulatory maze.
Directive 2002/98/EC - The Blood Safety Directive - Ruth Clayton and Roland Gordon-Beresford discuss the European Commission's open
consultation procedure.
European Commission Gives its Views on Implementing the Device Directives - Maureen Kenny outlines a report by the Commission and gives industry's response.
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Jul / Aug 2003 ( Vol 11 No 4 )
Features
Drug-Device Combinations Feature at DIA Annual Meeting - New products mean change in regulatory approach.
Keeping Pace with Industry: US Regulation of Drug-Device Combinations - Guy Furness looks at the FDA's new Office of Combination Products.
Commission Proposes to Alter the Medical Devices Directive - Maureen Kenny reports on proposals due to be adopted in July.
The MHRA after Three Months - A special report on the new UK agency.
NBOG Prepares Handbook for Europe's Designating Authorities - RAJ reports on efforts to improve notified bodies' performance.
Co-operation Among EU Member Ststes - Still a Long Way to Go - RAJ looks at the problems of one company.
The EU New Approach Directives Receive First Complete Review - Amanda Maxwell reports on proposals relating to Europe's medical device directives.
Reimbursement Policy in Germany - Joerg Schickert examines recent developments in German healthcare.
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May / Jun 2003 ( Vol 11 No 3 )
Features
EU Essentials 2 - A RAJ guide to the legislation and the decision making processes of the EU institutions.
Australia's New System of Medical Device Regulation - Staff at Australia's Therapeutic Goods Administration explain the new model
and the rationale behind the changes.
New Australian Device Regulation: Industry Viewpoint - The Medicinal Industry Association of Australia comments on the first six months
of operation of the regulations.
Reprocessed single-use devices and third-party inspections; changes resulting
from MDUFMA - Kenneth Sumner, Jeff Baetz and Diane Mandell continue their discussion of the
impact of new US legislation.
EU Essentials: The Community Patent - RAJ explains how the recently agreed common political approach will change the
European patent system.
Medical Device Regulatory Requirements in Argentina - Part two of a briefing by Miguel Napolitano on requirements for device approval
in Argentina covers approval procedures and labelling information.
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Mar / Apr 2003 ( Vol 11 No 2 )
Features
Medical Device Regulatory Requirements in Argentina - In part one of a two part briefing, Miguel Napolitano covers requirements for
device approval in Argentina including definitions and classifications.
Device Quality Systems - Joanne Beesley reports from the Medical Device Technology Conference 2003.
New Medical Device User Fees Required in the US - Diane Mandell et al discuss the impact of the new US legislation.
Electromagnetic Compatibility in the EU - Laura Nelson summarises EU measures relevant to medical devices.
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Jan / Feb 2003 ( Vol 11 No 1 )
Features
Denmark's New Medical Devices Act - Bente Lewinsky outlines the new primary legislation adopted by Parliament.
Reclassification of Borderline Medicines in Israel - Isaac Setton describes the new guideline on registration of borderline medicinal
products or medical devices.
The Propellant Transition: from CFCs to HFAs - Gareth Robinson captures the CFC regulatory story for metered dose inhalers.
Gateway to Latin America - RAJ reviews a new report on the market for medical equipment, devices and diagnostics.
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