As more and more healthcare apps enter the marketplace, manufacturers increasingly will wrestle with complex regulatory issues that don’t always have a clear path to compliance. For example, as functionality is added to software used in a healthcare setting, it can become a medical device in legal terms, writes life sciences and IP lawyer Erik Vollebregt on the Eucomed blog.
“Traditional device manufacturers will be faced with this as they provide additional software to make their devices more user friendly or effective,” writes Vollebregt, citing potential iPad apps that can remotely control or monitor a group of infusion pumps as one example. “The same will happen with IVD products, where expert system functionality becomes more and more important as the amount and complexity of raw data produced by IVDs keeps growing. Furthermore, the way stand-alone software is delivered to the end user is often radically different from the traditional model, so manufacturers must start to adopt a ‘device as service’ strategy,” writes Vollebregt in “Standalone software: objects in the regulatory mirror may appear simpler than they are.”
The theme of Vollebregt’s article, as you may have gathered, is complexity. If you are looking for clarity, by all means read his post on the Eucomed blog. You may also be interested to know that Vollebregt will be participating in a webcast on stand-alone medical software sponsored, as it happens, by medtechinsider and emdt.co.uk. To learn more about that, go to the registration page.Norbert Sparrow