In the context of Regulation (EU) 2017/745 (MDR), the concept of Technical Documentation has undergone a profound transformation with the MDR Product Record. It is no longer a static set of documents to be submitted for CE marking, but a dynamic system that accompanies the device throughout its entire lifecycle.
Today, for medical device manufacturers, the MDR Product Record represents this evolution: an information infrastructure that connects design, quality, regulatory, and post-market activities. Recent industry discussions, including those at the About Medical Devices conference last November in Milan, have clearly confirmed this direction. The value no longer lies in the single document, but in the consistency and governability of the entire system.
From the technical file to the MDR Product Record
The Product Record can be defined as the complete virtual dossier of the device. It does not simply collect information, but structures it and makes it traceable throughout the entire product lifecycle. It includes:
- Technical drawings
- Regulatory and technical documentation
- Production plans
- Product specifications
- Quality controls
Alongside these elements, two dimensions are becoming increasingly central: traceability of the device maturity lifecycle and the management of approvals by all involved stakeholders.
The result is a living system that must be constantly updated, consistent, and ready for audit.
An integrated system, no longer just an archive
MDR has imposed a clear paradigm shift: Technical Documentation is not only used to demonstrate compliance, but to ensure it over time.
This implies that the Product Record must interact with the quality system, post-market surveillance activities, and device traceability systems, up to European regulatory platforms such as EUDAMED. The most mature companies are already evolving toward centralized models, where content is managed as a critical asset, controlled in a structured way.
In this scenario, one often underestimated element clearly emerges: language management.
Language as a compliance requirement
In the Product Record, the multilingual dimension is an integral part of compliance.
The information accompanying the device must be available in the languages required by the countries where it is marketed. This clearly applies to labels and instructions for use, but also extends to other content that supports distribution, safe use, and lifecycle management of the device.
A still common risk is to treat translation as a final activity. In the MDR context, this approach quickly shows its limits. It generates misalignments, slows down releases, and can compromise the consistency of the dossier.
Translation and the MDR Product Record: a single process
If the MDR Product Record is a controlled system, translation must be as well. It cannot be an isolated step but must follow the same approval logic.
From this perspective, translation becomes a true function of document risk control. It does not only concern linguistic quality, but the consistency among all the information describing the device across different markets.
The most advanced organizations are already moving in this direction, integrating language flows into regulatory and documentation processes.
How to manage translation in the MDR Product Record: an operational approach
Define the scope of content
The first step is to precisely define which contents of the Product Record fall within the multilingual flow. Not everything needs to be translated, but everything that accompanies the device or supports its compliance in different markets must be identified and managed.
This activity makes it possible to avoid dispersion and to focus efforts on truly critical content.
Link documents, markets, and language requirements
Once the scope is defined, it is necessary to build a control logic that links each document to the target market and the related language requirements.
This step is what allows the management of European regulatory complexity in a flexible way, avoiding errors and duplication.
Translate only approved content
In the Product Record, translation must start exclusively from approved content. Each source document must have a clear status and a unique identifier before entering the language flow.
Anticipating translation before this step leads to rework and increases the risk of losing control.
Differentiate levels of content criticality
Not all content has the same impact. Regulatory information, such as warnings and intended purpose, requires a much higher level of control compared to other technical or informational content.
Recognizing these differences allows for more effective risk management.
Manage terminology
Terminological consistency is an integral part of product control. In a complex system like the Product Record, an inconsistent term can generate ambiguity between labels, instructions for use, and technical documentation.
For this reason, it is essential to have approved glossaries shared across different company functions.
Integrate translation into change control
Any change to the source content must trigger a verification of translated versions, especially when it concerns elements that are critical for the safety or performance of the device.
This ensures continuous alignment across all available versions.
Define approval workflows for languages
Translated versions must follow a structured approval process, with appropriate levels of control.
Each version must be traceable and linked to the source document, exactly as happens for the original content.
Manage eIFUs as dynamic content
With the spread of electronic instructions for use, language management becomes even more critical.
It is not just a matter of publishing content online, but of ensuring access to the correct version, consistency between versions, and controlled updates.
Prepare for the EUDAMED logic
The evolution toward EUDAMED reinforces the need for consistency between data, documents, and markets.
Unstructured translation management can quickly turn into a problem of information inconsistency.
Measure the process
To make translation a truly controlled process, it is necessary to monitor it over time.
Indicators such as language release time, number of rework cycles, and consistency between versions make it possible to progressively improve efficiency and reduce risk.
Conclusion
The Product Record is today one of the central elements for compliance and competitiveness in the medical device sector. It is no longer a document archive, but an integrated system that ensures control, traceability, and continuity throughout the entire device lifecycle. In this context, translation cannot be considered a downstream activity. It is a structural component of the process.
When the process is integrated, the Product Record truly becomes what MDR requires: a reliable, consistent, and sustainable system over time. When it is not, complexity and risk increase, and every update becomes a potential breaking point.
In a context increasingly oriented toward traceability, digitalization, and data centrality, the difference will not be made by those who produce more documentation, but by those who are able to govern it in a consistent, structured, and multilingual way.
Aglatech14 ContenTalkers
