mayo 19, 2025

What happens after May 26, 2025? UDI-DI compliance and market consequences

As of May 26, 2025, manufacturers of:

class I medical devices (under MDR)
class B and C in vitro diagnostic devices (under IVDR)

will be allowed to place or keep products on the EU market only if they meet all applicable UDI-DI requirements.

This also includes software devices, multi-unit packaging, and all packaging levels as defined in the relevant regulations.

Table of Contents

What changes from this date?

To comply with UDI-DI requirements, each relevant device must:

have a valid UDI-DI issued by an accredited organisation
display the code clearly on the label and packaging
reference the UDI-DI in the technical documentation

Registration in EUDAMED is not yet mandatory. This requirement will apply only once the database module is fully functional and officially declared operational by the European Commission.

Devices that do not comply will be considered non-compliant

Even if already placed on the market, a device that lacks proper UDI-DI implementation may be subject to enforcement.

Consequences of non-compliance

Failure to meet UDI-DI requirements after May 26, 2025 may result in:

rejection of new product batches
requests for corrective actions from competent authorities
supply chain disruptions
commercial setbacks with partners and distributors
risk of CE mark withdrawal or blocked access to the EU market

A regulatory threshold, not a procedural detail

This date marks the end of the transitional phase for UDI-DI obligations.

Manufacturers who are already compliant should focus on maintaining consistency across:

product labelling
technical documentation
post-market surveillance and quality systems

Those still working toward compliance should assess their current situation, define corrective actions, and be prepared to justify any delays during regulatory inspections.

UDI-DI compliance is now a regulatory obligation. Proper implementation across documentation and labelling is essential to maintain uninterrupted access to the EU market.