Software (embedded, standalone, Apps) has become more important in the medical field. Medical software is nowadays essential because of its multiple purposes in diagnostic, therapy, monitoring and others, and must meet the Medical Device Directives essential requirements before being placed on the market.
Like all medical devices, software must be classified to choose the route to demonstrate compliance with the Directive. However, the software classification rules were designed in the 1990s, so they may be difficult to apply to 21th century medical software. For this reason, the European community published an interpretive guidance (MEDDEV) for software classification specifically.
Understanding how your software is classified is essential for the success of your device in Europe and to ensure the software complies with the Directive. Classification allows you to determine what would be the control level of the Notified Body.
Join us for an informative webinar where we will go over the following points:
• Is my software a medical device in Europe?
• How to classify my software as a medical device?
• What are the risk classes of my device according to EN 62304?
• It is possible to combine a medical device with non-medical software?
• How to classify and manage non-medical software when it is combined with a medical device?
• Which conformity assessment route for the CE marking of my software?
• What is the applicable regulation for Software as a Service?
For the answers to these questions, and more, you can tune to LNE/G-MED North America’s webinar on Stand-alone software classification & regulation in Europe.