Coding regulations for medical devices

Coding regulations for medical devices

Regulations require not only that each device be clearly labeled
and coded for traceability, but in many cases that individual device
parts also be labeled and coded. These codes must be permanent
and clearly machine-readable, and may include alphanumeric codes
as well as a 1D and 2D bar codes and human-readable marks.

The full range of medical devices extends from low-risk items such as
Class I items (gloves, bandages, etc.) through Class II Moderate Risk
items (surgical sutures, infusion pumps, clamps, etc.) to Class III high
Risk items (replacement joints, heart valves, pacemakers, cochlear
and other implants). All of these items require UDI coding;
applying codes varies with the material in the device.

Many devices incorporate stainless steel components.
Medical device labeling of stainless steel components is done by
using fiber wire laser marking systems to place marks directly on
components or on plates attached to the devices. The higher power fiber
lasers create clean, precise marks with nanosecond pulses, ensuring high readability.

Laser medical device labeling engraves codes on stainless steel parts and products at the high speeds required by industrial production. Many of these laser machines are capable of engraving marks at up to 900 marks per minute, and can also direct their beams to mark targets as they move among production lines, supporting higher productivity. Non-metallic and flexible material items are more easily coded using inkjet or thermal transfer printing. These systems can apply permanent codes that are both human-readable and machine-readable, at production line speeds.

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Medical Device Regulation in the EU

Unique Device Identification System in the USA