The FDA has adopted a new rule to identify medical products and mandates that all medical devices be marked with a unique device identifier (UDI). Medical device manufacturers must mark 100% of their products when it comes to implant devices like bone plates and hip stems.
Manufacturers have many reasons to mark medical products. However, the tools and technologies available to do this are limited. Laser marking is a popular marking technology that offers many benefits to medical device manufacturers around the world.
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Needs of manufacturers
- Traceability: To improve patient safety, reduce product recalls and maximize market surveillance, medical devices must be marked.
- Product liability
- Protection from product piracy and trademark protection for product safety
- Product identification: This includes identification of the manufacturer, production, and the product itself
- Compliance with regulations, such as the UDI directive
- Process reliability and quality assurance
Producers must adhere to strict guidelines when marking contents. They need to make sure that the mark is placed correctly on the right part. These standards govern what must be marked (logotypes, 2D codes, or alphanumeric content) and where it has to apply.
This includes the assurance that the right part has been used to mark it and that it is being placed in the exact place that it should be marked (mark positioning).
The industry requests a variety of marking contents, including simple serial numbers, date and lot codes, images, graphics, and company logos or trademark logos. However, complex codes like 2D, barcodes, and multilanguage fonts are also required.