Product Categories

• Biochemistry [24]
• Biotechnology [6]
• Chemistry [34]
• Consumables [48]
• Engineering [68]
• Environment [6]
• Equipment Rental [1]
• Haematology [4]
• Health [10]
• Health & Safety [35]
• Imaging [18]
• Lab Design & Storage [47]
• Lab Services [28]
• Microbiology [18]
• Pharma [13]
• Recruitment [1]
• Sample Preparation [42]
• Separation Techniques [17]
• Software [43]
• Spectroscopy [12]
• Test Equipment [11]

OTHER CATEGORIES

• Associations [24]

Laboratory News Directory is not responsible for the content of external internet sites

Perfect harmonisation for medical devices

With the clock ticking for all manufacturers of medical devices, the adoption of a single European standard appears to be a significant step towards promoting safer diagnostic testing and cost-effective healthcare.

THE EUROPEAN directive to regulate in vitro diagnostic (IVD) medical devices has been a long time in the making. Historically, the regulations governing these devices have been fairly haphazard. The UK for instance has been generally unregulated in the area of IVDs whereas other countries such as France and Germany have been subject to very heavy regulation for many years. It was clear therefore that some kind of harmonisation was urgently needed in this rapidly growing diagnostic equipment area to help facilitate a single European market with a minimum of technical and trade barriers, hence the introduction of IVD directive (98/79/EC).

One of a family of four European Directives covering all types of medical devices, the primary purpose behind the IVD Directive is to ensure that only safe and effective products are sold within the European market, with a clearly outlined common regulatory environment regarding manufacturing, import and marketing.

The IVD directive defines in vitro diagnostic devices as any medical device which, whether used alone or in combination is intended by the manufacturer to be utilised for the in vitro examination of specimens derived from the human body, such as blood and tissue for instance. These devices may include instruments and technical apparatus, kits, reagents and even control material, all of which may be used to diagnose physiological and pathological states or monitor therapeutic measures. Thus the directive covers a tremendous range of products with a single piece of legislation, ranging from a simple test strip for glucose estimation to a fully automatic multi-analyser. To show compliance with the IVD directive, the 'CE' mark must be clearly displayed on a manufacturer's product before it is placed on the European market, and it can only be displayed if the device conforms to the requirements of the directive, thus does not compromise the health and safety of either patients or users. The potential value of CE marking to manufacturers and customers is therefore twofold, not only does it set a standard benchmark but it demonstrates a firm commitment to safe, quality products.

Discussions around the need for the legislative directives to create the single market initially began in the 1980s and have been on going ever since. The eventual timetable of the directive was staggered over a 5-year period to allow all the member states of the European Union to write and pass the necessary laws needed to transpose the directive into a common legislative framework. During this period, consumers will see some products with and some without CE marks as manufacturers begin to phase in their product ranges.

In December 1998 the IVD directive was officially published for the first time in the Journal of European Communities and should have been transposed by all the member states 12 months later, by December 1999, but as of November 2000 only 6 countries had actually done so, namely Sweden, Denmark, Finland, UK, Portugal and Spain. In June 2000 however it was transposed into UK legislation, and permitted manufactures to maintain their existing compliance but also start to CE mark their devices. A transition period however still allows the placing of current non-CE marked products on the market to continue, but this ended in December 2003.

From that time onwards the only new IVD devices allowed to enter the European market were those CE marked to indicate their conformity to the requirements of the IVD directive, however any existing device still in the distribution chain that conform to national legislation was still allowed to be marketed until December 2005. From then onwards, the directive states that non-CE marked products can no longer be marketed, and all IVDs must be CE marked. Following a number of recent revisions to the medical device directive however, all EU Member States now have until 21 December 2008 to transpose the new directive into national law. Following this, there is a further transition period for manufacturers to come into compliance by 21 March 2010.

As a result of these latest revisions, it seemed timely that the Medicines and Healthcare products Regulatory Agency (MHRA), the agency responsible for the regulation of all UK medical devices including IVDs organised a National one day seminar at their annual conference earlier this year in Birmingham to discuss these implications and the area of medical device vigilance in particular. Opening the seminar, MHRA chief executive professor Kent Woods remarked that this year would herald 'a new paradigm in safety', particularly in the wake of recent EU risk management legislation relating to all of its member states.

Professor Woods went on to outline the main objective of the proposed amendments. These essentially were to better specify the obligations of manufacturers, notified bodies and authorities with particular respect to key issues of conformity assessment, clinical evaluation and post market surveillance. This is in order to continue to ensure the highest level of safety, to ensure access to the market and to allow a smooth functioning of the legal framework. Vigilance was therefore seen in Birmingham by the MHRA as the key to reporting and investigating adverse incidents involving medical devices, which is why they chose this meeting to provide some valuable feedback on their recently introduced on-line reporting system 'MORE'.

Manufacturer's On-Line Reporting Environment (MORE) is described as the simple way for medical device manufacturers, suppliers and authorised representatives to submit adverse incidents reports to the MHRA. According to Roy Saunders, the head of the MHRA Adverse Incident Centre who himself was also actively involved in the design and implementation of MORE, the system is designed to provide a more convenient, user-friendly and secure reporting environment for medical device manufacturers to submit adverse incident reports. MORE allows medical device manufacturers to register, draft, edit and submit adverse incidents relating to their products in a totally secure environment. All submitted reports then receive an immediate electronic acknowledgement and unique reference number to be used in any subsequent follow-up investigations by the MHRA. Ultimately these reports and investigations may then result in potential corrective actions, product recalls, advisory notices, medical device alert warnings to healthcare staff and in some instances, the possible removal of the device itself from the marketplace.

With almost 600 registered MORE users now responsible for over 25% of all incident reports involving medical devices, the MHRA were confident that MORE will be seen as the mechanism of choice for manufacturers to use from now on, so much so that a new updated version MORE II has since been introduced on February 2008 as a result of a series of consultation exercises with MORE users.

Despite the undoubted success of the MHRA conference, Doris-Ann Williams, director general of the British In Vitro Diagnostics Association (BIVDA) who was in attendance and represents both manufacturers and distributors of IVDs believed that some aspects of the event missed the mark. "In my view there was no real acknowledgement of IVDs themselves, everything was focused towards medical devices as if IVDs didn't exist despite there being a number of IVD companies represented on the day. Also many of the presentations were often not relevant to the topic and the only presentation which examined the new medical device vigilance guidance 'MEDDEV Rev 5' was just an overview without any real interpretation of how the MHRA are implementing it and what they expect to change."

The long-term benefits of harmonised IVD and other medical device standards will ultimately result in both maintaining and improving the high quality of healthcare throughout Europe. Implementing the terms of the medical device directives however will be a major undertaking. The clock is now ticking, and for manufacturers there is no reason to delay the CE marking of their products, as waiting will only create further problems later. Because of this, most large multi-national companies have been planning ahead for the directive for many years. Alternatively other manufacturers slow to react may find that their products are no longer approved for sale.

Many challenges lay ahead ranging from displaying multi-language labeling changes on products to funding the associated new compliance costs involved, which may lead to the discontinuation of certain small revenue medical devices. As for the major medical device users such as pathology laboratories, the implications of the directive are significant. Medical science and laboratory testing in particular has a vital role to play in the correct and early diagnosis of disease and its cost-effective management. To achieve this it is essential therefore that only medical devices of the highest standard and quality are available in the marketplace. The medical device directives once fully implemented should now hopefully be a guarantee of this.

Delicious    Digg    StumbleUpon    Facebook