UDI '26: EUDAMED registration/compliance for medical devices
From 28 May 2026, registration of UDI/devices in EUDAMED will become mandatory. Manufacturers must clearly label and register their medical devices, keeping the data up to date. This will ensure complete traceability within the EU.
UDI requirement: What medical device manufacturers need to know
Unique Device Identification (UDI) is much more than just a label. It forms the basis for the digital registration and management of products in EUDAMED.
Manufacturers must ensure that:
- products are correctly labelled with UDI
- UDI data is fully registered in EUDAMED
- Data is regularly maintained and updated.
Without these steps, market access in the EU is not possible.
Challenges of UDI compliance
Implementing UDI requirements requires structured processes and regulatory expertise. Typical challenges include:
- Establishing efficient data processes
- Coordination with notification bodies
- Ensuring data quality
- Ongoing market surveillance
Aerochemica takes care of the entire UDI process.
As an ISO 13485-certified partner, Aerochemica supports manufacturers of medical aerosols in implementing all UDI requirements.
- UDI-compatible product labelling
- Registration in EUDAMED
- Digital maintenance of UDI data
- Registration of economic operators
- Communication with notification bodies
- Support with market surveillance
This ensures that your products remain legally compliant and marketable in a timely manner.
The advantages of choosing Aerochemica
With Aerochemica, you can reduce risks and complexity. You benefit from:
- Legal certainty and regulatory compliance
- Efficient processes and clear responsibilities
- More time for innovation, development and sales
Act now to meet the 2026 UDI requirements!
The deadline is approaching fast. Preparing early protects your market access and reduces operational risks.
Contact us today to find out how we can help make your product fit for 2026.