MDR
Description
The transition to the MDR represents the most significant change to European medical device legislation in decades. Unlike the previous directive, the MDR is a regulation, meaning it applies directly and consistently across all EU member states without need for national transposition. Its primary goal is to increase patient safety and ensure that new technologies are introduced to the market with sufficient clinical scrutiny.
For manufacturers, the MDR impacts the entire product lifecycle. It introduces a reclassification of certain devices, mandates the use of a Unique Device Identification (UDI) for traceability and requires extensive data submission to the EUDAMED database. Perhaps most significantly, it raises the bar for clinical data. Manufacturers must perform continuous clinical evaluations and post-market clinical follow-up to prove that their devices remain safe and effective over time. This shift creates a massive content challenge. Documentation such as the Clinical Evaluation Report (CER) and Instructions for Use (IFU) must be rigorously maintained, consistent and available in the official languages of the member states where the device is sold.
Example use cases
- Remediation: Updating legacy technical documentation to meet stricter MDR safety and performance requirements.
- Evaluation: Creating and maintaining CERs that align with continuous post-market surveillance data.
- Management: Ensuring instructions for use are accurate, consistent and compliant with legibility and language rules.
- Submission: Preparing and translating structured data for the European database on medical devices.
- Content: Drafting Summary of Safety and Clinical Performance documents in lay language for patients.
Key benefits
RWS perspective
RWS supports medical device manufacturers through the complexity of the MDR by combining regulatory expertise with intelligent content technology. We view compliance not just as a legal hurdle but as an information management challenge.
Our approach integrates Tridion Docs, our Component Content Management System (CCMS), with specialized Life Sciences translation services. This allows manufacturers to create a "single source of truth" for their regulatory content. When a clinical value or safety warning changes, it is updated once and propagated across all technical files, IFUs and translations automatically. Meanwhile, our linguistic experts ensure that every translation meets the precise terminology requirements of national competent authorities. By blending human regulatory insight with the control of structured content, RWS helps organizations navigate the MDR with confidence.