5 Critical Mistakes Still Common Among Class I Medical Device Manufacturers

With less than two weeks remaining before the EU MDR UDI deadline, Class I medical device manufacturers are still making preventable—but critical—errors. These mistakes are not just technical hiccups. They reflect deeper issues in data governance and can directly compromise regulatory compliance.

Here are the five most frequent mistakes still observed in the field:

1. Improperly Structured or Undeclared GTINs

Many manufacturers are using generic GTINs without having officially declared them to GS1. This leads to issues during audits or errors in EUDAMED entries. Without proper registration, these GTINs can be flagged as invalid—causing costly delays or outright rejection of submissions.

→ Tip: Always ensure GTINs are issued and validated through GS1. Avoid placeholders or assumptions.

2. Poor Management of Basic UDI-DI

Some companies define Basic UDI-DIs too broadly, grouping non-homogeneous products together. Others go to the opposite extreme, assigning one Basic UDI-DI per reference. Both approaches can lead to compliance problems, data redundancy, and confusion during regulatory reviews.

→ Tip: Structure your Basic UDI-DI hierarchy to reflect logical groupings of similar devices—neither too granular nor too broad.

3. Non-Compliant GS1 Labeling

Labels still frequently fail to meet GS1 standards: missing DataMatrix codes, incorrect placement, lack of human-readable text, or syntax errors (e.g., misformatted identifiers like (01)(17)(10)). The outcome? An unreadable or invalid UDI—automatically non-compliant.

→ Tip: Audit your labeling design. Ensure format, placement, and syntax strictly follow GS1 guidelines.

4. Poor Synchronization Between UDI and Internal Systems (ERP/PLM)

In many cases, UDI data is created in one system (e.g., PLM) but not properly propagated to others (e.g., ERP). This creates inconsistencies between what’s on the label, what’s in the system, and what’s registered in EUDAMED.

→ Tip: Ensure seamless data flow between your product lifecycle management tools and enterprise systems to maintain consistency across all records.

5. Incomplete or Inconsistent EUDAMED Registration

Frequent issues include missing mandatory fields (like the Authorized Representative), incorrect formatting, or broken links between the DI and Basic UDI-DI. These gaps often lead to registration blocks or delays that can jeopardize market access.

→ Tip: Double-check that all EUDAMED entries are complete, consistent, and formatted according to specifications.

The Underlying Truth?

These are not just technical mistakes—they're data governance failures. Without a centralized, structured, and validated data approach, errors are inevitable.

The EasyUDI Solution

EasyUDI centralizes your UDI data, automatically structures it, and validates every field before submission—minimizing errors and reducing compliance risks.

The Deadline Has Passed — Now What?

The May 26th deadline is behind us, but it’s not too late to correct errors, avoid penalties, and ensure ongoing compliance. Regulatory bodies will now be scrutinizing data more closely, especially for Class I devices.

If you're unsure about your current status or suspect inconsistencies, now is the time to act.EasyUDI can help you identify and resolve gaps, validate your records, and bring your data into full alignment with EU MDR and EUDAMED requirements.

Compliance isn’t a one-time task—it’s a continuous process. Let’s get it right.