The Medicine’s and Healthcare products Regulatory Agency (MHRA) have published an interactive guide that will help new and experienced manufacturers to navigate their obligations under new EU regulations on medical devices.
The new regulations are designed to include clearer obligations for those involved in manufacturing and supplying devices as well as greater emphasis on traceability throughout the whole supply chain. Some products will also become regulated under medical device legislation for the first time.
John Wilkinson, MHRA’s director of Medical Devices said:
“We live in an increasingly digital world, and the way we provide our guidance is changing. We want to help manufacturers to comply with the new regulations as easily and as early as possible. Our guidance is designed for all users – to help experienced manufacturers navigate the increased requirements for devices and diagnostics, as well as those manufacturers who will be new to the medical device regulations as a result of the broader scope of the new legislation.”