Common Packaging and Labeling Failures in Medical Device Inspection And How to Avoid Them

Medical device packaging and labeling play an important role in product identification, traceability and safe use. Under the EU Medical Device Regulation (MDR), manufacturers must ensure that device information is accurate, packaging meets the applicable requirements and sterile barrier systems maintain their integrity where necessary. A wrong UDI, an inconsistent lot number, or a damaged sterile package can hold up a shipment or lead to further quality investigations. These problems are often discovered during final inspection, when correcting an entire batch may involve additional time and cost. Medical device inspection therefore needs to go beyond checking the finished product's appearance. Labels, packaging and traceability records must also be checked against approved specifications before products are released.

Why Are Packaging and Labeling Critical Under EU MDR?

Under EU MDR, packaging and labeling serve several purposes: they identify the device, provide information needed for safe use and help preserve the product during storage and distribution. These requirements are addressed in different sections of Regulation (EU) 2017/745.

Annex I, Section 23 sets out general requirements for information supplied with a medical device, including label content, readability and placement. Section 23.2 covers information required on device labels. Section 23.3 adds requirements for packaging used to maintain a device's sterile condition. Section 11 also addresses packaging and procedures intended to preserve the specified microbial state and, where applicable, sterility.

For manufacturers and buyers, these requirements translate into three areas that need to be checked:

• Device identification: Product details, UDI information, lot or serial numbers and other identifiers must match the approved device records.
• Label information: Required text, symbols, warnings and manufacturer details must be accurate, legible and appropriate for the device.
• Packaging protection: Packaging must protect the device under the specified storage and transport conditions. For sterile devices, the sterile barrier must remain intact until the package is opened at the point of use.

The Unique Device Identification (UDI) system adds a further layer of traceability. It supports the identification of medical devices throughout distribution and use. Manufacturers are responsible for assigning and maintaining the relevant UDI information. The UDI carrier is an additional identification element, not a replacement for the other labeling information required under the MDR.

A further development took effect in 2026. According to the European Commission, the EUDAMED UDI/Devices module became mandatory to use on 28 May 2026. Manufacturers must submit the relevant UDI and device information for products placed on the EU market, subject to applicable MDR provisions and transitional arrangements. This makes consistency between physical labels, device records and registration data increasingly important.

Source: Welcome to EU UDI Helpdesk

What Are the Most Common Packaging and Labeling Failures?

Packaging and labeling problems do not always involve obvious physical damage. A small difference between a printed identifier and an approved record can affect traceability just as much as a damaged package can affect product protection. The following issues deserve particular attention during medical device inspection.

1. Incorrect or Unreadable UDI Information

UDI discrepancies can make it difficult to identify a device and trace it through the supply chain. Some errors are visible on the label, while others only become apparent when the encoded data is checked against the manufacturer's records.

Common problems include:

• UDI-DI or UDI-PI information that differs from approved device records.
• A mismatch between the human-readable text and encoded barcode data.
• Blurred, incomplete, distorted, or poorly printed barcodes.
• Missing or incorrectly positioned UDI carriers on applicable packaging levels.
• Label information that does not match the device model, batch, or production configuration.

A UDI carrier generally combines automatic identification and data capture (AIDC), such as a barcode or Data Matrix, with a human-readable interpretation (HRI), subject to applicable MDR rules and exceptions. Placement requirements depend on the device and its packaging configuration. Higher packaging levels may also require their own UDI, while shipping containers are treated differently.

Checking whether a barcode looks clear is not enough. An effective UDI label inspection should compare the printed information with the approved label artwork and device records. Representative barcodes should also be scanned to confirm that the encoded data matches the human-readable information.

2. Incomplete or Inconsistent Device Label Information

A label may be clearly printed and still fail to meet the applicable requirements. Examples include an incorrect device name, an incomplete manufacturer address, missing authorised representative details where applicable, or differences in model, catalogue, lot and serial number information. Incorrect warnings, symbols, expiry information and destination-market translations can also create problems.

MDR Annex I, Section 23.2 identifies the information required on device labels. Not every requirement applies to every device. Some particulars depend on the device's characteristics, intended purpose and regulatory status. The information supplied must also be suitable for the intended user.

For this reason, a single generic label checklist is unlikely to cover every medical device. Each production label should be compared with the manufacturer's approved artwork, product specifications and applicable regulatory information.

The review should look for:

• Text that differs from the approved label version.
• Missing or incorrectly printed product identifiers.
• Illegible text, symbols, or warnings.
• Incorrect manufacturing or expiry dates.
• Inconsistent information between the device, individual package and outer carton.

Version control deserves particular attention when a factory handles several device models or packaging configurations. If an outdated artwork file remains in use after a product change, the error may affect an entire production batch.

3. Sterile Barrier Damage and Sealing Defects

For medical devices supplied in a sterile condition, packaging integrity is directly linked to the ability to maintain sterility until the package is opened.

Visible defects may include incomplete seals, wrinkles across the sealing area, seal channels, punctures, tears, delamination, contamination and damaged packaging materials. Poor handling or unsuitable storage conditions can also deform or damage packages before shipment.

MDR Annex I, Section 11.4 requires sterile devices to remain sterile under the transport and storage conditions specified by the manufacturer, unless the packaging intended to maintain sterility is damaged. The packaging's integrity must also be evident to the final user. Section 11.5 addresses the use of appropriate validated methods for processing, manufacturing, packaging and sterilizing devices labeled as sterile.

A medical device packaging integrity inspection can identify visible signs of damage, but visual examination alone cannot establish whether a sterile barrier is effective. Seal strength, package integrity and process performance require suitable assessment methods under the manufacturer's established validation and control procedures.

For terminally sterilized medical devices,ISO 11607-1 addresses materials and sterile barrier and packaging systems. ISO 11607-2 covers the validation of forming, sealing and assembly processes. These standards provide technical frameworks for packaging control, but they do not replace the need to follow device-specific requirements and validated procedures.

4. Packaging Mix-Ups and Traceability Gaps

A product can pass its functional and appearance checks but still be packed incorrectly. For example, a correctly manufactured device may be placed in the wrong carton, or the lot number on the carton may not match the products inside. Such discrepancies can complicate warehouse handling, distribution, complaint investigations and product recalls.

Typical problems include:

• Different product names or model numbers on primary and secondary packaging.
• Lot or serial numbers that do not match between the device label and carton label.
• Incorrect quantities or mixed product variants in one carton.
• Missing or inconsistent manufacturing and expiry dates.
• Incomplete records connecting packaging materials, production batches and finished products.

A medical device supplier traceability audit can examine how the supplier manages material identification, batch records, production changes, nonconforming products and record retention. The key question is whether the supplier can reconstruct the relevant product and process history when a discrepancy occurs.

Read More: Inspection First: Smart Brands’ Guide to Quality Control

How Can Buyers Prevent Packaging and Labeling Failures Before Shipment?

A final inspection can identify problems in finished goods, but it cannot prevent every labeling or packaging error from occurring. Buyers and manufacturers need controls at different points in production, starting with approved product information and continuing through printing, packaging and final release.

1. Approve Label Artwork and UDI Data Before Production

The factory should use the latest approved label artwork and device information. Before production begins, buyers and manufacturers need to establish which version applies to each device model, packaging level and destination market.

The review should cover:

• Device name, model and catalogue reference.
• UDI-DI and applicable UDI-PI information.
• Lot or serial number format.
• Manufacturer and authorised representative details, where applicable.
• Manufacturing date, expiry date, warnings and required symbols.
• Required language versions and label layout.

A pre-production label review is particularly useful when a device, packaging supplier, or printing process changes. It gives the manufacturer an opportunity to identify inconsistencies before they affect a large quantity of finished products.

2. Check Labels and Barcodes During Production

A finished-product sample may not reveal printing problems that occur intermittently or errors introduced during a production changeover. In-process checks provide another opportunity to identify these issues before packing is completed.

The checks should cover label content, print quality, application position and barcode readability. Where barcode verification is included in the agreed inspection scope, representative samples should be scanned and the decoded data compared with the approved UDI information.

Factories should also follow line-clearance procedures when changing device models, batches, or label versions. This helps prevent labels intended for one product configuration from being applied to another.

How Can Medical Device Inspection Support Better Traceability Before Shipment?

Medical device inspection needs to cover more than the condition of finished products. UDI information, label accuracy, packaging integrity and supplier records all affect whether a device can be identified, handled and traced correctly throughout the supply chain.

Testcoo supports buyers through product inspections, packaging and labeling checks and supplier audits within an agreed scope. These activities help buyers review production conditions, identify discrepancies and improve visibility before goods leave the factory. For medical device manufacturers and importers, the value of inspection lies in having clear evidence of product and packaging conditions before shipment, while maintaining the manufacturer's responsibility for regulatory compliance and product release.