Clinical Evaluation Report (CER)
Description
The CER is a cornerstone of the EU Medical Device Regulation (MDR). It consolidates all available clinical evidence to validate the safety and performance of a medical device throughout its lifecycle.
Developing a CER involves multiple teams – from regulatory affairs and clinical experts to technical writers and quality managers – and requires strict document version control, traceability and documentation accuracy. The process includes literature review, data analysis, risk assessment and justification of equivalence to similar devices.
Authoring and maintaining CERs manually is time-consuming and error-prone. By adopting structured content authoring within a Component Content Management System (CCMS) like Tridion Docs, medical device companies can standardize terminology, enable real-time collaboration and ensure compliance through controlled access, metadata tagging and reusable components. Structured content allows authors and reviewers to work concurrently, maintain consistent taxonomies and update specific data points across documents instantly – improving quality and accelerating submissions to Notified Bodies.
Example use cases
- Regulatory submissions: Creating, reviewing and updating compliant CERs for MDR or IVDR.
- Concurrent authoring: Enabling multiple contributors to work within controlled workflows.
- Audit preparation: Maintaining traceability and documentation integrity for inspections.
- Data reuse: Leveraging standardized templates and components across multiple reports.
- Collaboration: Facilitating efficient communication between regulatory, medical and quality teams.
Key benefits
RWS perspective
RWS helps life sciences organizations modernize their regulatory documentation through structured content and intelligent automation.
Using Tridion Docs and structured authoring tools, RWS enables clinical and regulatory teams to produce audit-ready documentation that meets global compliance standards. Our solutions combine human expertise in regulatory writing with technology that enforces accuracy, reusability and control – transforming how CERs are created, reviewed and submitted. By embedding accessibility, structure and consistency into every stage of the authoring process, RWS empowers manufacturers to deliver high-quality, compliant CERs faster – while maintaining full confidence in their documentation.