Regulation (EU) 2017/745 (MDR) and related regulations have established a more stringent and transparent regulatory framework for EU medical devices and IVDR (in vitro diagnostic devices). Correspondingly,European Database on Medical Devices（EUDAMED）is designed to be the system’s “digital hub” — integratingmanufacturer / authorized representative / importer identity、device registration (UDI) / device information、Notified Bodies and certificates、market surveillance、post-market vigilance、clinical investigationsand other links, enablingfull-process traceability。

EUDAMED contains 6 modules:

• “Actor Registration”

• “Device / UDI Registration”

• “Notified Bodies & Certificates”

• “Market Surveillance”

• “Post-market Surveillance & Vigilance”

• “Clinical Investigation / Performance Studies” 

Over the past few years, these modules have been rolled out gradually and were allowed only“voluntary use”；but as regulatory implementation advances, compliance will become mandatory。

According to the notice issued by the European Commission on November 27, 2025,the first four EUDAMED modules have been confirmed to meet functional requirements，and have been published in the Official Journal of the European Union (OJEU)。

• This means that, as of May 28, 2026 the following four modules will be mandatory：

• Actor Registration

• UDI/Devices Registration

• Notified Bodies & Certificates

• Market Surveillance 
  

• For medical device companies (manufacturers / authorized representatives / importers / system and procedure pack producers, etc.),this is no longer “optional” — it isa mandatory requirement for entering or continuing to sell products on the EU marketa hard compliance threshold。

  
  

Therefore, for companies seeking to export to Europe or legally sell medical device / IVD products in Europe, the period from now until 2026-05-28 is the last opportunity to prepare during the “transition period”.

• Higher compliance thresholdIf Actor registration + UDI/device registration + NB/certificate registration + market surveillance information filing are not completed on time,this may directly affect CE certificate issuance, product export, placing on the market, and sales。

• Full-lifecycle oversight: EUDAMED connects the entire chain from“who manufactures / who serves as the authorized representative / who imports + what the product is + Notified Body + certificates + post-market surveillance / vigilance / reporting ” across the full chain, with transparency and traceability significantly improved compared with the past.

• Higher administrative compliance risk: Failure to submit required information through EUDAMED in accordance with the rules may lead to market access barriers, regulatory penalties, reputational damage, and more.

• Limited time window：With only ~6 months remaining until 2026-05-28, companies that have not yet started preparing need to initiate compliance actions immediately.

For Chinese medical device companies, this means: if you plan to enter or continue in the EU market through EU compliance / CE certification / EU market access,you must make EUDAMED registration / data remediation / UDI system integration / coordination with your Notified Body / product documentation preparation immediate priorities.

Applicable to: manufacturers (including Chinese manufacturers), EU authorized representatives, importers, and system and procedure pack producers.

What does the company need to do? (Submission can be completed in 10–20 minutes)

Step 1: Prepare the materials

Business license

Manufacturer / EU Authorized Representative information

PRRC information (Person Responsible for Regulatory Compliance)

Company address and contact person

Step 2: Submit Actor registration

Log in to EUDAMED → Actor module → upload the documents.

Step 3: Competent authority review (3–10 days)

For non-EU companies, the review is conducted by the Member State where the EU Authorized Representative is located .

Step 4: Obtain the SRN

This is the unique identifier for all subsequent modules

② Complete UDI / device registration (the most time-consuming task)

This is the step companies are most likely to underestimate

Step 1: Compile a product line list (mandatory)

Create an Excel sheet with the following fields:

Model

Risk class

EMDN code

Basic UDI-DI

UDI-DI

Packaging level

Step 2: Apply for / generate UDI

Via GS1 / HIBCC.

Step 3: Enter data in the EUDAMED Device module

Enter the following required fields:

Basic UDI-DI

UDI-DI

EMDN

Intended purpose

Packaging information

Manufacturer information

Step 4: Submit and retain records

③ NB certificate registration (must be uploaded by the Notified Body)

Actions required from the company

Step 1: Confirm the certificates cover the Basic UDI-DI

Otherwise, the NB cannot upload them.

Step 2: Notify the NB to upload the certificates on time

The company cannot upload them itself; this is a common misconception among many Chinese companies.

Step 3: Confirm within the system

Confirm that the certificate fields uploaded by the NB are correct.

Step 4: Regularly check certificate validity

Renewals and changes must all be synchronized.

④ Establish an internal EUDAMED update process (the most critical step once use becomes mandatory)

The company must establish 4 types of process:

1. Product change synchronization process

Changes to models, packaging, labeling, or manufacturing address → must be updated.

2. Certificate status update process

Renewals, changes, and scope extensions must be synchronized promptly.

3. PMS / Vigilance (post-market) process

Adverse events and Field Safety Corrective Actions (FSCA) must comply with the requirements of MDR Article 87–100.

4. Quarterly data review process

Ensure consistency across UDI, certificate, and product data.

⑤ Appoint a PRRC + establish an EUDAMED project timeline

This is an area many companies overlook

Responsibilities of the PRRC (Person Responsible for Regulatory Compliance) (MDR Article 15)

Review all EUDAMED data

Ensure products comply with MDR requirements

Oversee PMS / Vigilance data

Recommended project timeline (applicable to 2025–2026)

2025-12: Complete the SRN (Actor module) + complete the master product line list  2026-01: Generate the Basic UDI-DI / UDI-DI + prepare EUDAMED fields  2026-02: Complete ≥50% UDI / Device entry  2026-03: Complete upload of all NB certificates + company confirmation  2026-04: Internal data review (full verification of UDI, Device, and Certificates)  2026-05: Final PRRC review → full-module check → 5/28 mandatory go-live

The earlier you prepare, the less likely you are to miss the deadline and fail.
After May 28, 2026, all companies exporting to the EU must comply.