Medical device technical file
Description
For medical device manufacturers, the technical file is the passport to the market. Before a device can be sold in the European Union (under the MDR or IVDR) or cleared in the United States (where it aligns with the Device Master Record under FDA regulations), manufacturers must compile this file to prove compliance. It is not a static archive; it is a living body of evidence that must be maintained and updated throughout the entire lifecycle of the product.
The content of a technical file is extensive and interdependent. It typically includes the device description and specification, the Unique Device Identifier (UDI), labeling and Instructions for use (IFU), design and manufacturing information, benefit-risk analysis and the Clinical Evaluation Report (CER). Under stricter regulations like the EU MDR, the granularity and frequency of updates required for these documents have increased significantly. A change in a component, a new clinical finding or a post-market surveillance report must trigger synchronized revisions across the entire file.
Example use cases
- Certification: Compiling the mandatory technical documentation required for conformity assessment.
- Expansion: Using the core technical file as a "master dossier" to generate country-specific submissions.
- Surveillance: Updating the technical file with real-world performance data and safety reports.
- Audits: Providing a traceable, up-to-date history of design changes and risk assessments.
- Management: Automatically tracking the impact of engineering or labeling changes.
Key benefits
RWS perspective
RWS supports the creation and management of medical device technical files through a unique combination of regulatory expertise and intelligent content technology. We help manufacturers move away from disconnected document management to a structured content model using Tridion Docs.
This approach allows regulatory teams to manage technical files as dynamic, reusable components. When combined with our specialized Life Sciences translation services, it ensures that every part of the technical file – from clinical data to labeling – is accurate, consistent and compliant in every language. Our Human + Technology model ensures that while automation handles the data flow and version control, expert linguists and Subject-matter experts (SMEs) validate the accuracy of critical medical terminology.