UDI marking is coming - REA offers the turnkey solution

This is set to change: By the end of May 2025, all medical devices sold in the EU, Iceland, Liechtenstein, Norway and Switzerland will have to be clearly identifiable with a sequence of numbers as part of the "Medical Device Regulation" (MDR). For high-risk products (e.g. artificial joints), this will already be the case from May 2021. Medium-risk products (e.g. hearing aids) will have to be marked from May 2023 and low-risk medical devices (e.g. spectacles) from the end of May 2025. The overarching goal of all efforts is to increase patient safety.

Product identification with UDI

UDI (Unique Device Identification) is the name of the coding system that the European Union is currently establishing - coordinated with the USA and recognized by its health authority (FDA). The core of the system is a numerical code. It consists of a fixed front part (DI - Device Identifier), which is assigned to the manufacturers by four allocation bodies, and a variable rear part (PI - Production Identifier), which the manufacturers define themselves according to the specifications for the respective medical device. It is used for the individual identification and traceability of each part.

UDI is intended to make information about the origin and properties of a medical device available throughout its entire product life in case problems arise at a later date. The central database Eudamed (European Databank on Medical Devices) is to be set up for this purpose from May 2022. Every manufacturer will have to register every medical device there with its UDI before importers or distributors verify and supplement the data, which pharmacies, hospitals or medical practices will then also do. In this way, Eudamed seamlessly documents the history of each product.

In human readable text and as a machine-readable code

Accordingly, manufacturers have to label every medical device or its packaging with UDI - well positioned and in at least two forms: as human readable text and as a machine-readable 1D Code or 2D Data Matrix code. This can be done with ink, laser or a label.

This is where REA comes into play. As a full-range supplier, our REA JET, REA LABEL and REA VERIFIER product lines have long offered effective, economical and reliable systems for marking, labeling and code verification from a single source. All REA systems are suitable for Industry 4.0 - they can be seamlessly integrated into existing systems.

• The REA JET High Resolution Inkjet Printers print with HP Technology and extremely high resolution at high product speed.
• The REA JET GK 2.0 uses piezo technology and solvent-free inks to print on absorbent surfaces such as cardboard with high print quality and sharp edges.
• The REA JET SC 2.0 small character inkjet printer uses continuous inkjet technology to print texts, logos and codes on smooth surfaces (foils, plastics or metals).
• For permanent direct marking on plastic or metal, the REA LASER Systems are the right choice.
• REA LABEL labeling systems apply adhesive labels to any position on boxes and cartons of all packaging sizes.
• The code verification systems from REA VERIFIER provide legal certainty: they ensure that the marking is correct and error-free, that its quality complies with international standards and requirements and that the codes can be read by machine at the highest first-pass reading rate.

UDI presents medical device manufacturers with new challenges - REA systems stand for reliable, high-quality and permanent marking and code verification.

We are happy to support you in implementing the UDI directive.

• We have produced an easy-to-understand and helpful brochure on the subject of UDI, which you can download directly from the download box at the bottom of this article
• REA advises and trains you in UDI matters
• Finding competent partners for data management
• Suitability and use of coding and marking technologies
• Suitability and use of verification systems for compliance with code quality specifications