6Apr, 2020
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Conformity assessment procedures for 3D printed products to be used in a medical context for COVID-19
Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19. The European Commission has just released a guidance to assist manufacturers in ramping up production of essential medical equipment and material in above mentioned context. 3D Printers are NOT medical devices on their own, however such equipment need to comply with EU Machinery Directive 2006/42/EC and other applicable regulation, in order to be used for the purpose. 3D Printed product may constitute a medical device that fall under framework of Medical […]
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