Could your app be classified as a medical device? Recent research shows that this is often the case without companies knowing. Therefore, we set out the definitions, risks and requirements for health apps and software, providing you with practical tools to understand the framework your product might be in and we will also explain how to prevent falling within the medical device framework. As new European legislation is on the horizon, rules regarding medical devices have changed and the focus has shifted more towards the regulation of health software and apps. Also, the risk classification has become stricter, so it is suspected that certain health innovations will now also be categorized as medical devices. During this session, we will also provide you with some examples from our practice and inform you about the current reports from the Dutch government and the Healthcare Inspectorate regarding (future) enforcement (we've done the reading for you).
About Bird & Bird
Bird & Bird is an international law firm with over 30 offices globally, housing more than 1,350 lawyers and legal practitioners. Bird & Bird stands out because of our sector focus, building a single firm with lawyers having in depth knowledge of and deep-rooted passion for technology rich industries such as Life Sciences & Healthcare, Retail & Consumer and Technology & Communications. Over the last few years, as changes in technology have challenged all our sectors to innovate, we have grown together with our clients, developing deep industry understanding of their field and needs.
Bird & Bird focuses on one common goal: to be the number one firm in the world advising companies being changed by technology or the digital world.