After numerous delays, the first four modules of EUDAMED have now been audited, and their use will become mandatory in six months. This has been confirmed by the publication in the Official Journal of the European Union (OJEU) on 27.11.2025.

Many manufacturers have yet to engage deeply with EUDAMED. The UDI module, in particular, poses a challenge in meeting the mandatory usage deadline. With the audit now complete, the deadline for compliance is just six months away for medical devices certified under the MDR/IVDR. This article outlines everything you need to know about the first EUDAMED audit.

Which Parts of EUDAMED were Audited?

The European Commission (EC) initially planned to audit EUDAMED as a complete product, with all modules becoming functional and mandatory simultaneously. However, significant delays in developing the clinical investigations and performance studies module led the EC to deviate from this plan. Instead, the audit has now been completed for the following modules:

• Actor Registration
• UDI/Product Registration
• Notified Bodies and Certificates
• Market Surveillance

What Was the Purpose of the EUDAMED-Audit?

The audit aimed to determine whether the four EUDAMED modules meet the criteria of a Minimum Viable Product (MVP) – a product that is already usable and solves core user problems, though not yet fully featured. In EUDAMED’s case, this means the system enables stakeholders to meet the minimum MDR requirements and fulfill their legal obligations.

EUDAMED remains under development even after the audit. While an MVP is available, future changes are likely, especially affecting manufacturers using M2M interfaces or XML configurations. Continuous adaptation will be necessary.

The European Commission’s MVP requirements for EUDAMED can be found here.

What Are the Implications for Manufacturers?

With the audit’s completion published in the OJEU, the countdown begins:

• MDR-certified devices: 6-month transition period to register in the UDI module by 28.05.2026
• Legacy devices: 12-month transition period to upload master data by 28.11.2026

After these deadlines, non-compliant products may no longer be placed on the market. Enforcement actions such as sales bans, recalls, and fines may follow. MedTech companies must act quickly to enter their data into EUDAMED and remain compliant.

The other audited modules, Actor Registration, Notified Bodies and Certificates, and Market Surveillance, will also become mandatory from 28.05.2026, bringing additional responsibilities:

• Actor Module: Manufacturers must ensure they are registered and possess a valid Single Registration Number (SRN), which is required for all other entries.
• Notified Bodies and Certificates Module: All valid MDR/IVDR certificates issued by notified bodies must be correctly entered.
• Market Surveillance Module: Manufacturers must be able to respond to authority requests, provide safety-related information, and support product traceability.

When Will the Other EUDAMED-Modules Be Audited?

According to the EC’s official timeline:

• Vigilance Module: Expected to be functional between Q4 of 2026
• Clinical Investigations and Performance Studies Module: No release date yet due to development challenges

Both modules will become mandatory immediately after their respective audits. Note: Data in the UDI module forms the foundation for both. Without UDI compliance, compliance in these modules is not possible.

Our EUDAMED Webinar

To support manufacturers in meeting upcoming deadlines, we offer a free webinar introducing the basics of the UDI module. It’s ideal for companies that haven’t yet started or are unsure how to proceed. Advanced users will also benefit from tips to simplify UDI uploads.

Visit our [workshop page] or register via the following link.

Need a UDI Management Solution for EUDAMED?

Our UDI Manager simplifies product uploads and helps ensure timely compliance. Learn more about the mytracekey UDI Manager on our website. You can book the solution directly in our shop or schedule a product demo in advance.