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Recast of the medical devices directives

Are we doing enough to ensure in-vitro diagnostic medical devices are being cared for and used properly?

Jesús Rueda, Regulatory Affairs Manager EDMA, (European Diagnostic Manufacturers Association), Brussels, Belgium

In-vitro diagnostic medical devices (IVDs) are as ubiquitous as they are essential to modern healthcare. From the most complex of laboratory assays to the simplest home test for
blood glucose, IVDs influence the majority of clinical decisions today. Given their key role in healthcare, a valid question can be raised – what is being done to ensure that these devices are being used in a way that is consistent with a high level of protection of public health and safety? Both the way in which devices are used (eg, in the clinical laboratory) and the way in which the devices are designed and manufactured are key elements in ensuring that IVDs fulfil their promise of providing better healthcare. This article focuses on the latter element, particularly how the EU regulatory system functions as a framework to ensure that devices are manufactured so as to enable a high level of protection of public health and safety.

The keystone upon which the EU regulatory system for IVDs relies is Directive 98/79/EC on in-vitro diagnostic medical devices (IVDD). The IVDD is a new-approach directive, that is to say a piece of legislation that is independent of technology (relying on standards to provide technical details for compliance) and results in the affixing of the CE mark on devices compliant with it. Given that the CE mark is placed on the device itself, this also serves as a means of communicating to users of the device that certain key requirements have been fulfilled before the device was placed on the market.

The IVDD lays down requirements regarding performance, safety, and design instructions for use and requires that manufacturers demonstrate they meet these requirements, most notably through the use of a quality management

Quality management systems in turn are assessed by a third party, as are products that are considered to be of a high risk. It is for this reason that within the medical device field the CE mark has come to be seen as a mark of quality that is recognised not only within the EU but also beyond its borders.

Authorities have oversight of the entire system, with manufacturers registering their devices, and with all devices being subject both to market surveillance (the active verification by authorities that devices on the market are indeed in compliance) and the vigilance system (the investigation and follow-up actions following incidents in the field where devices fail to function as intended leading to a health risk).

The consequences of such a system are perhaps not immediately obvious at the level of users of IVDs. Compliance with the IVDD directly ensures quality, performance and safety of all devices concerned, as these are all requirements that manufacturers are required to meet.

Less obvious is the effect of the regulatory framework in shaping the kinds of products that are available on the market. If a regulatory framework is too onerous the cost and time required for entry into the market results in fewer devices being available for users, and can result in a delay in the adoption of new technologies.

The EU regulatory framework has been successful principally by fulfilling its role in ensuring that the devices that are present on the EU market are safe and fulfil their purpose, thus ensuring the protection of public health. Equally important is the role that the regulatory framework has in enabling new and innovative products to enter the market and demonstrate their value. Such products are in general available within the EU before other regulatory areas, without there being a compromise made on the safety or efficacy of these devices. This is a double benefit – to the users of IVDs who can benefit earlier from the newest technologies, and for the manufacturers of those same devices who see the competitive EU market as an incentive for the development of new devices.

In May 2008 the EU Commission, invoking its right of initiative to draft legislation, presented to all stakeholders a public consultation on the recast of the medical devices directives. In this consultation the EU Commission put forward revolutionary ideas to address a number of perceived problems within the regulatory system. This had the merit of stimulating a significant debate amongst all stakeholders to look carefully at the EU system, understand what works, what doesn’t and what can be improved. The initial proposals by the EU Commission include a package of reforms based on changes to the newapproach system itself. These aim to strengthen the market surveillance and vigilance systems – both of which help to ensure that only valid CE-marked devices that meet the applicable standards of safety and performance are available within the EU – and measures on the control and working of notified bodies – third-party assessment bodies that play a critical role in the technical oversight of manufacturers.

Such proposals constitute a natural evolution of the regulatory system and would, if implemented correctly, ensure a continued improvement in the field of diagnostics. However, there are other proposals that imply a far more fundamental overhaul of the regulatory system for IVDs. Any profound modification of the regulatory system would have as a direct consequence a disruption – to a greater or lesser extent – of the availability of analysers and reagents on the market. For this reason the proposals issued by the EU Commission are of importance not only to regulators and manufacturers, but also
to users of devices, who might find that the direct consequence of some of the changes being implemented is a reduced availability of devices in the medium to long term.

In particular it is worth highlighting the proposed codifications to the way the oversight of devices is carried out. Here, the suggestion on the part of the EU Commission to replace the existing framework by a central agency (possibly EMEA) needs to be looked into carefully as this will have important effects in the laboratory. The burden associated with the creation of this authority will ultimately have to be borne by the users of medical devices and IVDs. The key question is, does the creation of such a central body provide benefits that justify the costs of the system and the associated disruption to laboratories and to the market across the EU?

Regulations and directives on how diagnostic devices are to be produced may seem to be removed from the actual use of analysers and reagents in the laboratory. However, recent experience has shown this not to be the case. The introduction in 2002 of Regulation 1774/2002 legislating on the use of animal byproducts (basically any part of an animal not intended as a food), which in its original form included everything from tonnes of manure to purified antibodies, caused considerable havoc in the supply of reagents, particularly those coming from exotic animal sources to laboratories across the EU.

It is worth keeping in mind that this disruption was caused by a piece of legislation that was only tangential to the actual working of the regulatory system for IVDs. The recast of the medical devices directives, which will have a direct impact on the core regulatory system for IVDs, has the potential of having a much stronger impact – in particular, the fact of changing the nature of the regulatory system from the functional decentralised system that is in place today to a more centrally controlled agency system will have a significant impact.

Laboratories should be aware of the recast of the medical devices directives and consider the implications that this will have on their functioning, in particular as regards to the availability of devices and the potential financial impact
that putting such a centralised system into place would imply for the sector as a whole.

See EU Commission consultation:

For an extended position of industry on the recast see:

Decision N° 768/2008/EC, on a common framework for the marketing of products, lays downs the basis for the actual revision of the framework of the new approach, and Regulation N° 765/2008 sets out the requirements for
accreditation and market surveillance relating to the marketing of products within the New approach framework.