By May 28, 2026, the first four EUDAMED modules (Actors, UDI/Devices, Certificates, Market Surveillance) become mandatory for use, significantly raising the bar for transparency across the EU medical tech market. For manufacturers, this is not just another regulatory system to integrate. It fundamentally changes how post-market information is seen, reviewed, and judged.

The biggest shift is not the database itself. It’s what becomes visible.

Post-Market Surveillance (PMS) documentation, safety communications, and clinical summaries will be more connected, more frequently updated, and in some cases publicly accessible. That visibility turns translation-related regulatory and reputational risk into a business concern, not just a documentation task.

Why EUDAMED Increases Language Risk

EUDAMED was designed to improve oversight and trust. In practice, it also exposes inconsistencies across multilingual documentation sets.

Under EUDAMED:

• PMS documentation is reviewed over time, not in isolation
• Safety and performance information is compared across submissions and updates
• Public-facing documents sit alongside authority-facing reports
• Translated content is increasingly visible to regulators, healthcare professionals, and, in some cases, patients

A wording change in one report that does not carry through to another. A poorly translated patient summary. An outdated Field Safety Notice (FSN) still circulating in one market. These are no longer edge cases. They are exactly the types of translation-driven discrepancies that EUDAMED brings to the surface.

A Realistic Risk Scenario

Imagine this situation.

A device manufacturer updates a PSUR (Periodic Safety Update Report) to reflect a new safety trend. The English source is approved and submitted. Weeks later, a Field Safety Notice is issued and translated into multiple EU languages under time pressure.

In one market, the FSN uses terminology that does not fully align with the updated PSUR. In another, the patient-facing SSCP (Summary of Safety and Clinical Performance) still reflects older wording. None of the discrepancies are dramatic on their own, but together they create inconsistencies across documents now visible through EUDAMED and national regulatory channels.

A regulator reviewing the file sees different language describing the same risk. A healthcare professional notices the difference between the SSCP and the FSN. Questions follow. Notified Body or Competent Authority clarification requests are raised. Timelines stretch. Confidence erodes.

Nothing is technically “wrong,” but the language is no longer defensible as a system.

This is the kind of translation-driven regulatory exposure that EUDAMED makes easier to spot and harder to explain away.

PMS Becomes a Continuous, Multilingual Operation

Post-Market Surveillance has always been ongoing. EUDAMED formalizes that reality and increases the operational load for manufacturers subject to MDR/IVDR obligations.

PMS now generates:

• Recurring reports and updates across the life of the device
• Multilingual safety communications that must be released quickly
• Public summaries that must meet plain-language expectations
• Ongoing alignment across PMS, PSUR, PMCF (Post-Market Clinical Follow-up), and vigilance documentation

Each update creates downstream translation-related impact. Each language version must remain consistent not only with the source text, but with every previous version already on file.

Translation is no longer a final step. It becomes part of how manufacturers’ PMS documentation workflows function day to day.  

Where Translation Risk Shows Up First

For medical device manufacturers, the risk is rarely about volume alone. It’s about control over multilingual documentation over time.

Common pressure points include:

• Inconsistency across languages and document versions
  Small terminology shifts across updates can raise questions during audits or reviews.
• Public visibility of translated content quality
  Patient-facing SSCPs and Field Safety Notices are read closely, not just checked for completion.
• Time-critical delivery during safety events
  Vigilance communications demand rapid turnaround with zero tolerance for ambiguity or mistranslation.
• Fragmented translation workflows
  Ad-hoc processes make it harder to maintain traceability and alignment across markets.

Under EUDAMED, these pressures become more visible and harder to contain.

The PMS Documents That Drive Translation Demand 

Some PMS documentation remains authority-facing. Others are public and highly visible. Both drive sustained multilingual requirements depending on Member State language policies, device class, and Notified Body or Competent Authority practices.

Authority-facing documentation includes:

• PMS and PMCF plans
• PMS reports and PSURs
• PMCF evaluation reports
• Trend reports and vigilance narratives
• Field Safety Corrective Action documentation

Public-facing documentation includes:

• SSCPs, for healthcare professionals and patients
• Clinical investigation and performance study summaries
• Field Safety Notices (FSNs)

The challenge is not translating these documents once. It is keeping them accurate, aligned, and defensible over time as documentation evolves across markets and regulatory submissions. 

How Welocalize Helps Reduce Translation-Driven Risk 

Welocalize helps medical device manufacturers support the translation of PMS-related documentation generated under their MDR obligations, treating translation as a lifecycle discipline rather than a series of disconnected requests.

We support clients by:

• Maintaining consistent terminology across PMS, PSUR, PMCF, SSCP, and safety communications
• Reducing translation-related regulatory and reputational risk as documentation evolves
• Scaling multilingual updates across EU markets without losing control
• Enabling rapid, controlled response during vigilance and safety events
• Supporting audit readiness with regulated, traceable workflows

EUDAMED increases transparency and scrutiny. Welocalize supports the translation of PMS-related documentation generated under manufacturers’ regulatory obligations, helping reduce translation-related regulatory and reputational risk across the medical-device lifecycle.

What Makes Translation Defensible Under EUDAMED

Not all translation processes are built for regulated transparency.

Under EUDAMED, manufacturers increasingly need translation support that offers:

• Document-level traceability across updates and versions
• Change-driven workflows that prioritize modified content rather than reprocessing entire documents
• Audit-ready records of terminology decisions and updates
• Lifecycle consistency between PSURs, SSCPs, FSNs and vigilance narratives

These capabilities are what allow multilingual PMS documentation to remain defensible as a system, not just accurate at a single point in time.

The Bottom Line

EUDAMED does not just increase regulatory expectations. It increases exposure of multilingual documentation to regulators, healthcare professionals, and, in some cases, the public.

In a more transparent environment, translation quality becomes a strategic concern. Inconsistent or unclear language can slow reviews, complicate audits, and undermine trust at exactly the wrong moment.

Welocalize helps Medical Device manufacturers support the translation of PMS-related documentation generated under their regulatory obligations, making multilingual documentation more predictable, consistent, and controlled over the device lifecycle.