UK Issues Guidance on 3D Printing of Devices During Pandemic

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released a new guidance on 3D printing of medical devices during the COVID-19 pandemic.

The agency explained that the regulatory requirements for 3D printing depend on whether the product is considered a medical device or a piece of personal protective equipment, noting that 3D medical devices must meet all the requirements in the EU’s Medical Devices Directive to gain a CE mark.

“Manufacturers must be able to demonstrate how they have met the high levels of safety and performance expected from all medical devices,” the agency said.