3D printing (additive manufacturing) of medical devices or component parts during the coronavirus (COVID-19) pandemic

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance for organizations using 3D printing to produce medical devices and personal protective equipment (PPE) during the COVID-19 pandemic. Because 3D printing introduces different material properties and risks compared to traditional manufacturing, manufacturers must adhere to strict safety standards to protect users and patients. Medical devices must comply with the Medical Devices Directive/Regulations to obtain UKCA or CE marking, while PPE must meet PPE Regulation 2016/425. The guidance identifies several critical issues, including potential biological toxicity from printing chemicals and the need for rigorous mechanical testing for parts containing pressurized gases. To ensure safety, manufacturers are required to validate every stage of the process, including cleaning, disinfection, and sterilization. They must also provide scientific evidence that final products are non-toxic, following ISO 10993 standards. While the MHRA may grant exceptional use authorizations for non-marked devices during a clinical crisis, applicants must still demonstrate high levels of performance and safety. Manufacturers are encouraged to collaborate with original part designers to ensure specifications are met and to document the exact composition of all materials used in the printing process.