Medical devices and Unique Device Identification

15.05.2019
Yleinen

Following the pharmaceutical industry, also the medical devices industry is facing regulatory changes. These include the US FDA regulations and EU MDR (Medical Device Regulation), replacing the older MDD (Medical Devices Directive), as well as India and China.  Other markets are considering or developing similar regulations.

One of the fields facing regulatory changes has been product marking. Product identification and traceability have become important in medical devices as has been the case in medicines. As an example: hospitals have been struggling with differing product codes from different suppliers and wholesalers. As a result, demand for standardized identification codes, i.e. Unique Device Identification (UDI). Unlike in pharmaceutical products, full serialization is not required, however: batch level product identifiers are allowed, product-level serial numbers as an option. For higher packaging levels, EU requires an own UDI up to, but not including, a shipping/logistics container. The requirements to package or device marking will come to force starting from 2021, beginning from Class III devices.

Another big difference is Direct Part Marking: products that will be used multiple times after being extracted from their packages, such as surgical tools, are often required to have marking directly on the product. In the EU this must be in both machine and human-readable form. As the reusable (disinfectable) device surface is often metallic, it is obvious that implementing this differs from the package printing solutions used in e.g. pharmaceutical packaging. Laser marking is one option here. Quality control of the marking with e.g. vision inspection systems is also needed.

The UDI can also be left to the next higher level packaging, except where the healthcare provider is not expected to have access to the higher level packaging. In case of space constraints on the label in individual devices or device packages, the machine-readable code (AIDC) is enough.  An exception are devices to be used in home care, where human-readable code (HRI) is required and machine-readable can be excluded. There are also other exceptions to the rules concerning the marking.

The main drivers for UDI are to improve patient safety and efficiency in healthcare and healthcare logistics. Unified machine-readable device identifiers, such as the widely used GS1 GTIN on Data Matrix or barcode, simplify healthcare inventory processes. Common cloud-based databases, such as EUDAMED in EU, provide the master data to the healthcare applications — provided, of course, that the manufacturers upload all the data as regulatory authorities require.

Servicepoint offers services of an experienced full-service device assembly and packaging, machine vision, robotics, and serialization and traceability automation integration company. We have long served major international medical device manufacturers with device assembly and quality inspection automation. In the last few years, Servicepoint has also implemented serialization to more than a dozen sites for several pharmaceutical manufacturers, our implemented projects at customers ranging from Russia to Spain, from Finland to Cyprus.  Call us, we can help you!

Servicepoint Oy — the reliable partner for the manufacturing industry

Iiro Jantunen
TkT, Teknologiajohtaja
Servicepoint Kuopio Oy
iiro.jantunen@servicepoint.fi
+358 44 7868 215