Wedding bells are ringing for the proposal of new IVD regulation

  • Posted on 18.09.2012

Wedding bells are ringing for the proposal of new IVD regulation


Jesús Rueda Rodríguez

Director International Affairs MedTech Europe



Eucomed has joined forces with EDMA, the European Diagnostics Manafacturers Association in an alliance of European medical technology industry associations. This week, EDMA Regulatory Affairs Director, Jesús Rueda Rodríguez, shares his views on the upcoming revision of the EU In Vitro Diagnostics Directive.


I have always found that no matter how much a person looks forward to a change, there is still that little tad of reluctance – a fear that things may not turn out for the better. The hesitation, even if momentary, manifests itself in the simple and mundane everyday tasks like clicking install for a computer software update or taking life’s big leaps, like getting married. The concern for what the change may bring is all the greater when you didn’t really mind the way things were in the first place. From my experience, some of us in the in vitro diagnostics (IVD) industry are also experiencing a bit of such reluctance when it comes to the revision of the IVD directive. Especially when it has worked fine since 1998, so why the change? A reasonable question, but considering the differences that have arisen between the healthcare context of the late 1990s and today, it’s time that our industry give the proposal careful consideration in the lead up to its approval, taking into account the impact of each of the legislation’s proposed aspects.

Before taking a blind plunge, there are some things that we have to keep in mind, some that we still have to work toward and some that can be explained by a good luck wedding proverb.

Something old symbolises continuity – bringing a bit of the past into the future. The overall acceptance and workability of the IVD Directive has meant that many of its aspects will simply be transferred into the new legislation. There is no need to fix something that isn’t broken and in this case, the important thing is to ensure an environment favourable to innovation is created and definitions are improved definitions, but there is no need to demolish the past.

Something new shows hope for the future and in the context of the IVD legislation, the opportunity presented is one of improved patient care. From more diverse companion diagnostics to new point of care testing devices, the legislation should offer a healthy balance between adequate pre-market safety controls, efficiency and appropriate use that will foster innovation.

Something borrowed indicates the sharing of good fortune by someone with close ties to the bride, which for the European IVD industry would be the Global Harmonisation Task Force (GHTF) and its classification system. The GHTF classification will replace the current IVD classification, meaning that some IVDs will be subject to more stringent controls, but as long as the associated pre-market approval takes into account the unique risk profile of IVDs, this will not have a detrimental aspect on market access.

Something blue The Commission’s new approach was initially summarised in the Blue guide, describing regulatory principles for products that circulate freely on the single market. Though the guide has since been revised, the IVD Directive will better reflect single market principles, including an impact on notified bodies and regulation distribution practices.

And a silver sixpence is intended to evoke a notion of financial prosperity, something that the IVD industry is uniquely capable of doing for European healthcare. Though an IVD may require a financial investment initially, it can result in the early detection of an illness and more targeted treatment, which would mean fewer unnecessary medical costs and better patient outcomes.

So while the bells ring to begin the next chapter of the proposal for the new IVD regulation, it will bring about some significant changes and predictably cold feet. So let’s not cave in but buckle up for a tidal wave of new prospects, new challenges and sustainable matrimony between regulation and innovation in the coming years.

– Jesús Rueda Rodríguez, Regulatory Affairs Director, EDMA

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