Understanding Change Control in MDR/IVDR Compliance

The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have transformed localization into a discipline focused on change management. It’s no longer a matter of “Translate once and then forget.” Instead, it demands ongoing lifecycle management.

A single adjustment in the Instructions for Use (IFU), whether it’s a new warning or updated storage conditions, can affect:

• Multiple languages
• Various formats, including IFU, labeling, and package text, as well as web content
• A variety of stakeholders, including individuals from Regulatory Affairs, Quality Assurance Management, Marketing departments, and distribution channels
• Numerous versions that must remain consistent for audit purposes

When considering which strategies or approaches are effective in real-world situations, it is important to analyze the factors that may influence outcomes.

What we can recommend is to implement the following:

• Translation update: focus only on modified segments, while ensuring that a comprehensive record of the entire history is kept (important for audit purposes)
• Terminology governance: particularly critical for warnings, contraindications, and product claims, which is crucial in regulatory environments where precision and accuracy can significantly impact patient safety as well as compliance
• Traceability by default: ensure clarity from the source version to the translated version and through to approvals (an audit-ready localization pipeline means traceability – versions, reviewers, approvals, and predictable quality for regulated documentation; this way, you can demonstrate a controlled process for multilingual content)
• Proof in context: the final step that helps in avoiding costly mistakes in labeling and packaging: in practice it means proofreading the translation in its final “real” environment, e.g. in the actual UI screen for software and app strings, or in the web page for online product information
• Quality metrics: systematically monitor and evaluate key performance indicators, and analyze trends over time. Risk-based acceptance criteria we suggest include:
  • Defining Critical/Major/Minor errors
  • Zero tolerance for Critical in safety label sections

What we see is that companies that succeed under MDR/IVDR are typically those that effectively manage change and have processes in place, rather than avoid them.