November 2004 – Volume 1, Issue 1

Welcome editorial

Haroon Atchia and Ralph Jugo, members of the Journal of Medical Device Regulation’s Editorial Advisory Board, discuss the importance of this type of international Journal in the medical device arena for promoting a better, wider and hopefully more uniform approach throughout the regulatory domain.

Positioning medical devices when reimbursement is not an option (1)

A technology’s prospects for ‘reimbursement’ refers to three interrelated processes: its prospects for insurance coverage, the billing and procedure codes assigned to it and the actual payment, if any, it will generate when used. In most instances the procedures using the technology, and not the technology itself, generate reimbursement. Consequently, the price of the technology can become a major barrier to product adoption unless additional payment is built into the procedure reimbursement or the purchaser becomes convinced that the technology brings clinical and economic value that is not tied to the procedure reimbursement itself. Manufacturers need to quantify technology ‘value’ in ways that are meaningful to purchasers and users in order to successfully position medical devices.

In Part 1 of this article, Nancy L Reaven gives examples of some of the most common reasons why reimbursement is not available for medical technologies in the US and discusses strategies for overcoming resulting barriers to product adoption. Part 2, which will be published in the February 2005 issue, she will focus in more detail on the financial incentives and perspectives motivating technology purchasers and suggest various approaches to relevant ‘value’ analyses.

Nanotechnology and product liability issues

The implications that new technologies such as nanotechnology could have on the health of the population are an area of great public concern. Jason Bright summarises what is meant by ‘nanotechnology’ and questions whether the current regulatory controls for these products are adequate. He also reviews the legal framework in place for dealing with product liability claims arising from these new technologies and urges manufacturers to have up-to-date and rigorous risk management strategies in place to deal with any potential claims.

21 CFR Part 11: catching up with the past

Even though 21 CFR Part 11, the US FDA’s Rule on Electronic Records and Electronic Signatures, was promulgated in August 1997, many of the technical controls mandated in the Rule are nothing new to the GxP regulated industries. As the medical device, pharmaceutical and biotechnology arenas struggle with Part 11 compliance, the strategies for analysing their GxP systems and creating their plans and procedures for Part 11 remediation should contain some of the old familiar strategies for validation, security and the protection and management of regulated records. This article by Victoria Lander identifies what is unique to Part 11 and what, on the other hand, has been drawn directly from the GxPs.

In vitro diagnostics: the grey areas of Directive 98/79/EC

As stakeholders and governing bodies struggle to assess the proper application of the European Directive on in vitro diagnostic medical devices (IVDs) to manufacturers, purchasers, distributors and users, a number of grey areas as to the correct interpretation of its provisions are emerging. Sandra King sets out the general framework and background for the legislation and looks in more detail at these grey areas, in particular, the concept of manufacturer and the implications of off-label use for a user of a device. Her article concludes that, while the practical effect for an off-label user of a device is probably limited to relieving the original manufacturer of liability, there are adverse implications for European-wide competition in one particular context of potential off-label use. These implications result from the manufacturer’s prerogative to limit its liability by narrowly confining the scope of the device’s ‘intended purpose’, the yardstick by which proper and improper use are measured for that device.

To e-label or not to e-label; that is the question

For years, medical device manufacturers have recognised that electronic labelling could provide many of the benefits that it has in other industry sectors. However, labelling is one of the most closely regulated elements of a highly regulated industry. In order to ensure that users have the information they need to apply a device correctly, regulators have to be convinced that electronic labelling will be adequate to maintain the safe and effective use of the device. Electronic labelling is still not widely accepted outside the USA, and this article by Charles Sidebottom examines the US FDA’s more liberal approach and compares this to other key markets such as the EU and Canada.

ISO 13485 for the medical device industry

International standards used by the medical device industry have gone through many significant changes in the past 10 years. Firstly there were the revisions to the ISO 9000 series, followed by supplemental requirements for medical devices introduced through the EN 46000 family of standards and latterly ISO 13485: 1996. However, it soon became evident that two topics in ISO 9001: 2000 would cause particular concern for the device industry, namely customer satisfaction and continual improvement, and that the level for compliance had been raised making the standard unsuitable for regulatory purposes. Alternative options were considered and, in 1999, it was finally agreed that a specific, standalone standard for the medical device industry should be developed. The result was the publication of ISO 13485: 2003 last year. Paul Sim uses this article to summarise the content and format of this standard, discuss its current status and applicable transition periods and make general recommendations to manufacturers on implementation. In a forthcoming issue of the Journal, Paul will continue his discussion of ISO 13485: 2003 by providing practical advice on how to successfully implement the standard.

European Update

• Czech guidance documents issued
• Legislative summary for the Czech Republic
• Danish Medicines Agency’s Performance Contract 2004-7
• Finnish National Agency for Medicines relocates
• New French laws published on bioethics, personal data and public health policies
• France fails to transpose Directive 2000/70/EC
• Germany acts to provide safer blood products
• 2nd DRG Amendment Law passed by German Cabinet
• New quality institute established in Germany
• Irish Medicines Board issues four safety notices
• On-line vigilance reporting system established in Ireland
• Swiss device regulations amended
• UK MHRA Annual Report and Accounts 2003/4
• UK Device Evaluation Service’s Annual Report for 2003/4
• Committee on the Safety of Devices
• Medical Device Alerts issued by UK MHRA

US Update

• User fees for FY 2005
• FDA’s priorities for the next six months
• Premarket approval requirement for orthopaedic devices
• Classification of beta-glucan serological assay
• Sirolimus test system devices
• Special controls for dental devices
• Classification of silicone sheeting
• HAV serological assays: proposed reclassification
• CDRH Annual Report for FY 2003
• Menstrual tampon labelling
• Modifications to List of FDA Recognised Standards
• New proposed documents from GHTF
• Information collection activities
• Final and draft guidance documents

International

• Trans-Tasman regulation of therapeutic product advertising
• Excluded therapeutic goods in Australia
• GMP audits and manufacturer’s clearances
• New TGA fact sheets
• Australia’s MDEC comments on use of symbols
• TGA’s impact statement on human tissue-based products
• Draft guidance on device licence renewals in Canada
• Reusable and single-use devices: the Canadian view
• Canada’s GGP and GRP initiatives
• New device registration process introduced in China
• Other device news from China
• International trademark registration
• Free trade agreements
• Classification amendments in Taiwan

Environment Update

• Packaging and packaging waste
• Electrical and electronic waste Directives

Standards Update

• Transition period ends for medical EMC standard
• Diagnostic ultrasound standards revised

Reference Information

• Book review: Biological Safety & European Medical Device Regulations
• Meeting report: TCT ‘Town Hall’
• Elemental essentials: the CE mark
• ‘New Approach’ regulations – Part 1
• Country focus: Argentina