There has been so much media and political focus on the medical device legislation in Europe in the first four months of 2012 that one could be forgiven for losing track of what’s exactly going on and where we are exactly in the process. Especially as we now have Commissioner Dalli’s joint action plan with [...]

For medtech companies, interacting with Healthcare Professionals (HCPs) is a fact of life. HCPs are an integral part of the R&D process and a source of innovation and creativity throughout the development of medical devices. HCPs are also the prime users of technologies and play an instrumental role in the successful adoption of innovative medical [...]

January 2012 was a fruitful month for EU guidance on medical devices and produced among other MEDDEVs the MEDDEV 2.1/6 Qualification and Classification of stand alone software. This MEDDEV contains the latest thinking on how stand alone software, i.e. software that does not necessarily run on a medical device (but may have medical device functionality), [...]

Let’s flip the European innovation model on its head Innovation is synonymous with progress. Embracing innovation means embracing the need to improve the sustainability and efficiency of healthcare systems by encouraging new business models, unlocking new market opportunities and improving health outcomes. Uptake of innovation in technology and services, however, could be quicker on the [...]

Centralised procurement of medical technologies is an increasingly prevalent phenomenon in the EU, and one that all stakeholders in this field, whether for or against it, have strong opinions on. Purchasers have embraced centralised procurement as a means to drive down costs. Suppliers fiercely oppose it as it would limit market opportunities and slow down [...]