From 28 May 2026, some core modules of the EU EUDAMED system became mandatory. The one manufacturers care about most is UDI/Device registration – the UDI and device registration module.
This means that for medical device companies planning to enter the EU market, UDI is not just a code on the label or a compliance chapter in the technical documentation, but essential basic data determining whether the product can complete EU market access smoothly and be identified effectively by importers, authorized representatives, notified bodies and competent authorities.
Many companies used to have a simple view of UDI: get a code from GS1 and the UDI requirement is done. In fact, under the MDR, UDI is a complete system of product identification, traceability and regulatory data. It involves product labels, packaging and IFUs, as well as EUDAMED registration, consistency with technical documentation, supply chain traceability and post-market surveillance.
UDI stands for Unique Device Identification. Its core purpose is to allow every medical device to be accurately identified and traced within the EU regulatory system.
In the past, EU medical device regulation relied more on CE certificates, declarations of conformity, product labels and Member State databases. With the MDR, the EU wants a more unified, transparent and traceable regulatory system, and EUDAMED is its core platform.
The importance of UDI registration lies mainly in three areas.
First, it is the product’s “regulatory ID card”. A company may have multiple models, sizes and packaging levels; without uniform UDI rules, regulators, importers, hospitals and users find it hard to determine which technical documentation, CE certificate, risk class and manufacturer responsibility a product corresponds to.
Second, it is the foundation for post-market surveillance and recalls. When adverse events, field safety corrective actions or recalls occur, companies need to locate quickly the affected batches, models and distribution. UDI helps companies accurately identify problem products on the market, avoiding recalls that are too broad or that miss high-risk products.
Third, it is key to the consistency of EU market access documents. UDI information is linked to labels, IFUs, declarations of conformity, technical documentation, CE certificates, EU AR information and importer information. If early coding and registration logic is muddled, problems may surface later during notified body audits, customer due diligence, platform verification or authority inspections.
2. What Does the MDR Require for UDI and EUDAMED Registration?
In the MDR, UDI requirements are mainly in Article 27, Article 28, Article 29 and Annex VI.
Article 27 establishes the EU UDI system, requiring a unique identification mechanism for medical devices. Article 28 provides for the UDI database. Article 29 further requires that, except for custom-made devices, manufacturers enter device information into EUDAMED before placing the device on the market, or verify it where the information already exists, and keep it up to date.
Simply put, in future a company cannot just say “my product has a CE certificate”; it must be able to state: what is the product’s Basic UDI-DI? Which UDI-DIs correspond to each model? Has the product been registered in EUDAMED? Is the registered information consistent with labels, certificates and technical documentation?
Companies must clearly distinguish two concepts: Basic UDI-DI and UDI-DI.
The Basic UDI-DI can be understood as the main identifier at the level of a product family or registration unit. It is not a barcode printed directly on the label but a key identifier used to link EUDAMED registration, the CE certificate, declaration of conformity and technical documentation.
The UDI-DI is the device identifier at the level of a specific model or packaging level, usually appearing on labels, packaging or barcodes to identify the specific product sold. Under one Basic UDI-DI there may be several UDI-DIs for different models, specifications, sizes, pack quantities or configurations.
Besides the UDI-DI, a full UDI may also contain the UDI-PI, i.e. production identifiers such as lot number, serial number, date of manufacture and expiry date. The UDI-DI answers “what product is this”; the UDI-PI answers “which batch or which unit is this”.
3. Can Companies Make Up Their Own UDI Codes?
The MDR requires UDIs to be generated according to the rules of an issuing entity designated by the EU. Common issuing entities include GS1, HIBCC and ICCBBA. Each has different coding rules and data structures, and companies should choose based on their products, customer requirements, existing barcode systems and global market strategy.
For most Chinese medical device companies, GS1 is a common choice, especially where products already involve hospital procurement, retail packaging, cross-border trade or global supply chain management. But whichever issuing entity you choose, remember one principle: a UDI is not a string of numbers generated ad hoc for registration; it should be part of the company’s product life-cycle management.
Before generating UDIs, companies should at least confirm the following:
How are registration units or product families divided? Can different models and specifications be grouped under the same Basic UDI-DI? Which changes would require a new UDI-DI? Do packaging levels need separate codes? Will the label show a 1D barcode, 2D code or other data carrier? Is UDI information consistent across ERP, labeling systems, technical documentation and EUDAMED registration data?
Without planning these questions in advance, problems easily arise later, such as “codes obtained but registration logic inconsistent”, “labels printed but EUDAMED data cannot be completed”, or “the Basic UDI-DI on the certificate doesn’t match internal records”.
4. Which Changes May Affect the UDI?
Companies also need to pay special attention to UDI change rules. Generally, changes in a product’s intended use, risk class, basic design, models/specifications, pack quantity, sterile status, single-use status or key safety performance may affect the UDI-DI or EUDAMED registration data.
For example, a product originally supplied non-sterile is later supplied sterile; a product originally in single packs gets an additional multi-pack sales unit; a product originally only model A gains models B and C. Not all such changes necessarily require a new Basic UDI-DI, but at a minimum you need to assess whether a new UDI-DI is needed or the device attributes in EUDAMED need updating.
So UDI management cannot be handled ad hoc by the regulatory department alone; an internal process should be established with R&D, production, quality, labeling, supply chain and sales. Companies should assess the UDI impact whenever there are design, label, packaging or registration changes.
5. How Should Companies Prepare Now?
For companies that already hold MDR CE certificates or plan to enter the EU market, we recommend the following as soon as possible.
First, confirm whether the company has completed Actor registration and obtained an SRN (Single Registration Number). Without an SRN, subsequent device registration and linking of EU economic operator information will be affected.
Second, review the existing product list and build a UDI register by product family, model, specification, packaging level and certificate scope. The register should clearly map Basic UDI-DI, UDI-DI, product name, risk class, certificate number, declaration of conformity, label version and IFU version.
Third, check how UDIs are shown on labels and IFUs and confirm compliance with the MDR and the chosen issuing entity’s rules. Companies exporting to several countries in particular should avoid mixing EU UDIs, US FDA UDIs and internal material codes.
Finally, prepare the product data needed for EUDAMED registration and check it for consistency. EUDAMED registration is not just filling in a form; it is a comprehensive test of the quality of the company’s product master data.
The arrival of mandatory UDI registration in EUDAMED means EU medical device regulation is moving further from “document compliance” to “data compliance” and “life-cycle traceability”.
For companies, UDI registration is not an isolated action but foundational work within the MDR compliance system. It affects whether products can be placed on the EU market smoothly, as well as subsequent notified body audits, importer checks, platform verification, customer tenders and regulatory inspections.
If your company already holds EU CE certificates but has not yet systematically reviewed its UDI and EUDAMED registration data, now is the time to start. The earlier you establish clear product coding and data management logic, the lower the cost of later registrations, changes and market maintenance.
EVERBIZ can help medical device companies with EU UDI rules, Basic UDI-DI and UDI-DI planning, EUDAMED device registration, label and IFU compliance review, MDR technical documentation consistency checks and EU Authorized Representative services, ensuring a smooth compliance transition as EU requirements change.
EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria), Thailand, Vietnam, Singapore and Malaysia, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).
Shanghai: Room 909, Building 1, Lane 111 Luxiang Road, Baoshan District, Shanghai, China; Germany: Landsberger Str. 155, 80687 München, Germany
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Hong Kong: Room A1, 11/F Winner Building, 36 Man Yue Street, Hung Hom, Kowloon, Hong Kong
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