In this issue
Issue 40 • June 2021
The European Union’s new Medical Device Regulation (MDR) has finally come into force, with all medical devices now required to adhere to a new set of rules and requirements before they can be sold or imported into the region.
While the MDR has been a long time – almost ten years – in the making, that doesn’t mean that device manufacturers will be fully prepared for how the transition may change their operations. As the new rules expand the definition of a medical device, software developers may find that their product now falls under the scope of MDR.
To find out more, we speak to international law firm Morrison & Foerster to discuss the changes coming into play for medical device software as the MDR is rolled out, from intended use and risk classification to the complexities of unique device identification.
Elsewhere, we get to grips with the next generation of medical wearables, find out how an AI-powered healthcare marketplace is helping the NHS to secure PPE supplies and examine the ethical issues surrounding the use of mechanical wombs to artificially gestate human embryos.
For all this, plus the latest insight and analysis from GlobalData, read on.
Eloise Mclennan, editor