From FDA to CE: Key Points for Global Compliance with UDI

UDI labeling of medical devices must meet the requirements of both the FDA and the CE mark. The key is selecting a laser marking device that uses suitable materials and is software compatible.The FDA stresses timely updating of databases, while the CE focuses on tracing the entire life cycle. In practical terms, attention must be paid to compatibility of materials, interfacing of software, and periodic quality inspections.Manufacturers should establish a comprehensive management system covering everything from equipment selection to data submission, to avoid problems with product labeling that can result in products being barred from the market.

Why is the UDI so important?

If medical devices want to enter the US or European markets, they need a UDI (Unique Device Identification). This is like the "ID card" for a product. Without it, they can't go anywhere.The FDA and CE have different priorities with regard to UDI requirements. The FDA mandates that manufacturers update their databases within seven days. The CE, on the other hand, places more emphasis on traceability.For manufacturers, the choice of the right type of laser marking equipment directly affects the permanence of the marks and the success rate in reading them.

How can you choose a reliable laser marking machine?

Choose the right materials.

Different types of medical instruments require different types of lasers.For example, metal products are better cut with fiber lasers, while plastics are better cut with UV lasers. Don't expect one machine to be able to cut everything.

Don't overlook compatibility.

A good labeler should be able to link directly to the GS1 database and automatically generate UDI codes that meet the standard.I've seen too many companies that have had to manually re-enter data because of software incompatibility, which cuts efficiency in half.

From FDA to CE mark.

Three steps to the FDA.

First, register a business account on the GUDID database, then complete the device classification. When uploading UDI data, pay special attention to the separation of the DI (device identifier) and the PI (production identifier). This has caught out many first-timers.

Key points of CE certification.

Besides satisfying the MDR, it is important to clearly state UDI management responsibilities in the EU representative agreement.Last year, a company was blocked from the EU market for three months because its EU representative didn ’ t update its UDI data in a timely manner.

Maintenance cannot stop.

He suggests that a quality check of the labels should be carried out quarterly, and that the durability of the labels in damp environments should be tested.The most extreme case I've seen was when the labels were corroded by sea salt and the entire shipment was scrapped.