Two years ago in our annual report on the medtech sector, Pulse of the industry, we warned that the sector was facing a perfect storm, caused by a general shift toward value-based care, growing regulatory pressure in the US and limited resources as a result of a global downturn. Those events came to pass, with the added complication of tougher new regulatory issues in Europe. It was time, we felt, in this year’s report to see how the sector is weathering the storm.
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), qualifies as medical device under the three medical devices directives. If you are interested in a lot more background about the MEDDEV than I can provide in this blogpost (and especially nice flowcharts, which make life more simple for everyone), you can find it here.