Learn more about medical device labeling regulations, including Unique Device Identifier (UDI), electronic Information for Use (eIFU) and the differences between regulations in the US, EU and China.
labeling is deemed "a critical component of a medical device."1The standard provides comprehensive requirements for medical device marking and labeling. All information for safe installation, use, storage, servicing, and maintenance of the device must be provided...
Medical device manufacturers who want to sell in Europe or other parts of the world must comply with the EU Medical Devices Directive (MDD). The MDD sets out specific requirements for the design, manufacture, testing, labeling, quality assurance/quality control procedures, and post-market surveilla...
While each standard addresses specific medical device products, they collectively emphasize requirements for performance, testing, labeling, and safety measures. Here is a summary of what the newly introduced standards addresses as tailored to specific medical applications and technologies: Medical Inductively...
IEC 6060 1-1 treats labeling as a critical component of the device and provides comprehensive requirements for marking and labeling. The standard requires all information for safe installation, use, storage, servicing, and maintenance of the device to be provided to the user. The standard requires...
ISO 15223-2008 Medical devices Symbols
using the medical device, may suffer from certain diseases or aggravate the disease; (eight) other contents prohibited by laws and regulations. The name of the product of the tenth medical instruments shall conform to the corresponding standards and regulations of the state. The product ...
Seventh medical device manuals shall conform to the relevant requirements of the state or industry standards, and shall include the following contents in general: (1) product name, model and specification; (two) production enterprise name, registered address, production address, contact information and...
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Medical device labeling applications Easily design and print barcode labels that are compliant with medical device industry standards. UDI compliant labels Design labels of all sizes HIBC andGS1Databar barcode creation Accurate labels for medical devices ...