The European Medical Device Regulation has formally replaced the Medical Device Directive, imposing a new set of requirements on the marketing of medical devices in the EU that will significantly alter the way that manufacturers organise and approach translations for product packaging. We hear from Professor Dr Herman Pieterse to find out how the new system will impact packaging and labelling requirements in Europe, and what companies can do to prepare for compliance.

With machine learning primed to break into the mainstream over the next few years, we take a look at the latest studies and technological developments helping to make a name for AI in the medical field, and find out how Cyberdyne’s Hybrid Assistive Limb exoskeleton will fit into the market for rehabilitation devices in the US. Plus, ALE healthcare division leader Nicole Hill explains how healthcare providers can prepare for the second wave of digitisation, with technology now involved in every step of the patient journey

As always, we also round up the latest news from the medical device industry, and get comment and analysis from GlobalData’s healthcare analysts on market dynamics, product innovation, regional developments and regulatory issues.

Eloise McLennan, editor