EUDAMED Mandatory Use in 2026: A B2B Due-Diligence Checklist

Four EUDAMED modules became mandatory to use on 28 May 2026. For B2B teams working on products that fall within the EU Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR), this changes the evidence that should be checked during project qualification and distributor due diligence.

The change does not mean that every aesthetic product is a medical device, and EUDAMED is not a certificate. Product classification, economic-operator duties and market access must be assessed for the actual product and intended market by appropriately qualified parties.

What changed on 28 May 2026?

The European Commission’s EUDAMED overview confirms that four modules became mandatory to use:

Actor registration
UDI/Device registration
Notified Bodies and Certificates
Market Surveillance

The change followed Commission Decision (EU) 2025/2371, published on 27 November 2025, which declared the first four modules functional and triggered a six-month transition period. The remaining modules for vigilance and post-market surveillance, and for clinical investigations and performance studies, are still being developed or analysed according to the Commission’s current overview.

For B2B buyers, the practical lesson is not to request “an EUDAMED certificate.” The useful task is to verify the relevant records, roles and data for the specific project.

Verify EUDAMED actor registration

The Actor module supports registration of relevant economic operators and the allocation of an Actor ID or Single Registration Number (SRN). The Commission states that the module is mandatory from 28 May 2026.

During a B2B review, record which entity is expected to act as manufacturer, authorised representative, importer or another relevant operator. Do not infer these responsibilities from a brand name, website footer or commercial contact alone.

Useful due-diligence questions include:

Which legal entity holds the relevant role?
Is an Actor ID or SRN applicable to that role and project?
Does the legal name match the associated project documentation?
Who is responsible for maintaining the registration data?

The European Commission’s Actor registration page provides the official module description and current guidance links.

Review UDI/Device registration data

The Commission states that manufacturers must submit UDI/device information for devices they place on the EU market, where the MDR or IVDR requirements apply. In a project review, UDI data should be treated as structured product information rather than as a generic marketing identifier.

Check whether the proposed device name, model or version, responsible manufacturer, UDI data and packaging hierarchy are consistent across the records being reviewed. A representative product image or preliminary artwork should not be used to fill gaps in the registration data.

This is also why packaging and documentation must be planned together. See our guide to aesthetic product packaging and documentation paths for a practical way to separate representative visuals, project specifications and controlled records.

Check notified-body and certificate records

The Notified Bodies and Certificates module contains information entered by notified bodies about certificates, including changes in status. The Commission notes that this information is accessible to the public.

For qualified projects, compare the certificate holder, scope, status, dates and relevant product information with the actual commercial proposal. A certificate associated with one legal entity, product scope or version should not be generalised to another project.

The official module page explains the information registered by notified bodies and the module’s mandatory-use date.

A B2B EUDAMED due-diligence checklist

Before treating EUDAMED information as part of a commercial decision, confirm:

Whether the specific product and intended purpose fall within the applicable MDR or IVDR route.
The legal entities and economic-operator roles for the target market.
The product, model, version and packaging presentation under review.
Whether the Actor, UDI/device and certificate records apply to that exact scope.
Whether names, identifiers, dates and statuses are consistent across public and controlled sources.
Which questions require review by the buyer’s regulatory, legal or technical specialists.
Who will record the decision, open points and next review date.

This checklist should sit inside a wider project brief. Our B2B OEM/ODM project brief guide explains how to capture the target market, buyer role, packaging direction and documentation questions before controlled materials are requested.

Keep public and controlled information separate

EUDAMED increases access to structured information, but it does not remove the need for controlled project review. Public records can help verify identities and status. Product-specific specifications, batch records, formulations, internal quality files and commercial terms may still require a qualified inquiry, confidentiality controls and version tracking.

Innovision Bio coordinates B2B project discussions, while GuangLong is the manufacturing and R&D entity for the relevant product lines. Those roles must remain distinct from the legal roles and responsibilities applicable to a specific EU-market project.

Review the Innovision Bio product portfolio to identify the category and presentation under discussion. When the target market and documentation questions are ready, submit them through the B2B project contact route.

This industry update is for professional B2B planning only. It is not legal, regulatory or medical advice, and it does not determine product classification, registration status or market access. Verify the current official requirements and obtain qualified advice for the specific product, entity and market.