Class I medical devices could previously be placed on the market without a Unique Device Identification (UDI) under certain conditions. Since 26 May 2025, the mandatory UDI requirement also applies to products in the lowest risk class. Anyone wishing to place their products on the market after this date must have fully complied with all regulatory requirements. Important: Registration in the EUDAMED database remains optional for the time being.
UDI Standardised Traceability in Medical Technology
The Unique Device Identifier (UDI) is an internationally established system for the unique identification of medical devices. It increases transparency in the supply chain, improves traceability and enhances patient safety. The UDI system consists of various components, including a base code (Basic UDI-DI) and a product-specific code (UDI-DI), which is affixed to the product or packaging in a machine- and human-readable format.
Classification and Background: Why the Requirement Now also Applies to Class I
With the entry into force of the Regulation (EU) 2017/745 on medical devices (MDR) on 26 May 2021, the introduction of UDI became mandatory throughout Europe. To give manufacturers sufficient time to adapt, the requirements were introduced in stages:
- For higher class products (IIa, IIb, III), the requirements have already been in force since 2021 and 2023, respectively.
- A transition period applied to Class I products which ended on 26 May 2025.
- Class I reusable products that must be directly marked will be granted an extension until May 2027.
Until now, it was permissible to place new Class I products on the market in accordance with the MDR without a UDI, provided that they were CE-compliant and correctly registered. With the expiry of the transition period, this option will no longer be available.
What Manufacturers Must Now Implement in Concrete Terms
From 26 May 2025, only Class I products that meet the following criteria may be placed on the market:
- The product has a complete, MDR-compliant UDI carrier (e.g. barcode, DataMatrix code) on the packaging or product.
- The product is clearly assigned to a product type with a Basic UDI-DI.
- The manufactuer can give a complete UDI strategy in the technical documentation for the product.
- For class I products placed on the market in Germany: A registration in the DMIDS is required.
Manufacturers with a broad product range, private label solutions or OEM/PLM constellations should analyse their processes now and adapt them if necessary.
Who Is Subject to the UDI Requirement?
This affects not only manufacturers in the narrow sense, but also:
- Importers of products from third countries,
- EU authorised representatives,
- Distributors who repackage or relabel products and thereby become ‘manufacturers’ within the meaning of the MDR.
Important: Those who are considered responsible economic operators bear full responsibility for the correct implementation and registration of UDI.
BEO BERLIN – Your Partner for Regulatory Security
The implementation of the UDI requirement brings with it organisational, technical and strategic challenges. The good news is that you do not have to do it alone.
BEO BERLIN has been supporting companies in the medical technology sector for many years in all regulatory matters – with pragmatism, partnership and professionalism. Our services relating to UDI include, among other things:
- Development of a UDI strategy,
- Support in assigning and structuring UDI-DI and Basic UDI-DI,
- Taking over or assisting with EUDAMED registration,
- Preparation of technical documentation in accordance with MDR and MDCG guidelines.
Our YouTube Tutorial: Registering UDI in EUDAMED – Step by Step
How exactly does registering a UDI in the EUDAMED database work? What information must be provided? What preparatory steps should be taken, and what information can you leave out? You will find the answers to these questions in our practical YouTube tutorial, in which we guide you step by step through the EUDAMED registration process. Beware: The tutorial is spoken in German, but we added Englisch subtitles for our international audiencee
Conclusion: Act Now – UDI Is Mandatory, not Optional
26 May 2025 was a binding deadline – after that date, no UDI means no placing on the market. Anyone who misses the deadline risks being banned from the market and having to recall products. Affected companies should therefore check and adapt their systems, labels and register entries now.
Are you unsure whether you have implemented all requirements correctly?
BEO BERLIN is at your side with experienced regulatory affairs specialists. Together, we ensure that your products remain compliant and safe on the market in the future.
Contact us – we will be happy to advise you.
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