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Home » UK Issues Guidance on 3D Printing of Devices During Pandemic
UK Issues Guidance on 3D Printing of Devices During Pandemic
June 15, 2020
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.
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