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EU releases medical device regulations (MDR)

03-09 海讯社

The EU Medical Device Regulation 2017/745 is about to enter into force, which will require manufacturers to identify medical device labels distributed within the EU as unique device marking (UDI) specific codes.

For those who export medical equipment, be sure to understand what UDI is? Otherwise, it will affect your business development, and you may miss hundreds of millions if you accidentally.

What is UDI encoding?

UDI (Unique Device Identification) consists of a fixed device identification (DI) and a variable production identification (PI).

UDI must be available in both human-readable (plain text) and machine-readable formats, which use Automatic Identification and Data Acquisition (AIDC) technology.

  

At present, UDI coding only affects the import and export of medical devices. Whether it will affect all medical device industries in China in the future is uncertain, but China is also making rules for the unique identification system for medical devices (draft for comments), perhaps in the near future. UID coding is also performed in medical devices.

Where should UDI code be applied?

UDI codes must usually be attached to a first- or higher-level medical device package. Containers are not part of a higher level medical device packaging. Since the GTIN (Global Trade Item Code, the identification code issued by GS1) is unique to each level of medical device packaging, the UDI code is unique for each level of packaging.

Some exceptions:

• If the primary packaging has a very limited identification space, the UDI code may be identified on the secondary packaging.

• For individually packaged Class I and Class IIa disposable medical devices, such as medical gloves, the UDI code can be identified on the secondary packaging.

• For re-use of medical devices, such as surgical instruments, the UDI code must be directly identified on the medical device itself, unless direct identification has an impact on its safety or performance, or is not technically feasible.

Advantages of CYCJET in pharmaceutical and medical device compliance with UDI rules in technical solutions

CYCJET offers a range of solutions that comply with the UDI Act. CYCJET inkjet printers have been the standard solution for high quality coded printing on medical device packaging for more than a decade. In addition, CYCJET's high-resolution portable inkjet printers have a large installed base in the pharmaceutical industry. The CYCJET printer can print on medical device packaging in accordance with GS1 standards and UDI code.

The Printing Display of CYCJET Portable Inkjet Printer:

The CYCJET industrial inkjet printer incorporates an integrated concept during design, as evidenced by the integration of a large number of tested thermoformed packaging equipment. Ideally, the printer should be placed in a position before the closure web is heat sealed. The compact design of the CYCJET printer allows it to be placed in tight spaces that are typically left in most packaging equipment. A common method is to move the print head laterally along the web so that multiple products can be coded in a single pass during dwell (the web is stationary at the machine's moving gap). The solution can drive up to four independent high-speed nozzles to evenly align each row of products to meet mobile speed requirements without sacrificing productivity.

Advantages of CYCJET High Resolution Solutions

CYCJET marking machine is suitable for medical devices (such as medical dialysis paper or DuPontTM 1059 b and 1073 b Tyvek ®) of the base of common blocks. In addition, the CYCJET printer interface offers a wide range of connectivity options to support job information from external databases and handheld barcode scanners. High-resolution inkjet printers are capable of high-speed inkjet coding without sacrificing code resolution. The printer can quickly and easily replace ink cartridges in less than 15 seconds, and simply wipe the cartridge print array and printheads for maintenance, providing unparalleled simplicity. Each time you replace an ink cartridge, the print array is renewed, which helps ensure optimal performance and maximizes uptimeThere is no need to replace consumables or maintenance consumables, and no calibration procedures are required, which helps to reduce setup and maintenance time.

Conclusion

Preparing production lines and equipment for UDI coding requires careful planning, and CYCJET can help you determine the ideal solution for your production line. CYCJET works closely with a number of key OEMs to help ensure that our coders are seamlessly integrated into your existing packaging line and that your UDI coding process is perfectly matched to your business needs.

CYCJET is the brand name of Yuchang Industrial Company Limited. As a manufacturer, CYCJET have more than ten years of experience for wholesaler and retailer of different types of handheld inkjet printing solution, Laser printing solution, portable marking solution in Shanghai China.


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