Jesús Rueda Rodríguez

This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com. Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage, How to create and maintain an ethical culture,  Progress and new challenges after 10 years of collaboration, Distributors play key role […]

In the last few weeks we have seen the emergence of a new global public health threat, the Zika Virus (ZIKV). Both the World Health Organization (WHO) and the European Centre for Disease Prevention and Control (ECDC) are monitoring the spread of the Zika, a mosquito borne arbovirus. The WHO recently declared the diseases linked […]

When the European Parliament finalised their amendments for the Proposal for a Regulation on in vitro diagnostic medical devices in October 2013, they set the scene for a process that has continued through several Council Presidencies. The continued discussions are a reflection of the complexity of the file and the need for careful consideration of the technical aspects of the text, which should lead to the creation of a positive environment for innovation, safety and patient access across Europe.

Getting the timing right for the implementation of changes is essential to ensuring that the new regulations result in a better system for IVDs rather than a bureaucratic quagmire.  The sweeping changes being made to risk classification will be complex and time-consuming.  The lessons learned from similar overhauls in other markets show us that a period of transition is essential to optimise the implementation of changes for the new European IVD legal framework.

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.