Building Audit-Ready CERs — Meet Article 61 & Annex XIV with CAPTIS®

Clinical Evaluation Reports are central to EU MDR technical documentation. Article 61 and Annex XIV require that clinical claims be demonstrably supported by up-to-date evidence, linked to risk management, and maintained throughout the device’s lifecycle. This article discusses how an integrated platform such as CAPTIS^® helps teams deliver audit-ready CERs with greater speed and consistency.

What Reviewers Now Expect

Notified Bodies and MDCG guidance emphasize transparent methods, reproducible Systematic Literature Review (SLR)/State of the Art (SOTA) outputs, and direct links from claims to source data. Key reviewer expectations include:

• Clearly defined clinical claims with measurable criteria.
• A documented SLR/SOTA methodology (search strings, databases, date ranges, PRISMA-style flow).
• A traceability matrix that links each claim to the evidence, related RMF entries, and PMS/PMCF actions.
• Version control and an update plan tied to device risk and specific triggers.

If these elements are missing, reviewers commonly issue formal findings — implement a living traceability matrix, strict version control and documented reviewer signoffs to prevent delays.

How to Build a Traceability Matrix

Following the below steps can make the Traceability Matrix operational:

• Define clinical claims – Phrase each claim which is specific to a patient’s benefit and map it to specific safety and performance endpoints which are measurable.
• Capture appropriate source information – For every extracted data includes database, DOI, page/location, and so verifiers can find the original quickly.
• Link to Risk Management – Connect claims to RMF entries showing how residual risks are accepted and mitigated.
• Tie gaps to PMS/PMCF actions – For any evidence shortfall, document the PMCF objective, planned study or survey details along with expected completion timelines.
• Date and version of every change – Maintain a clear audit history which identifies the changes along with the rationale. When this matrix is kept current, the CER becomes a single source of truth that accelerates internal review and external assessments.

A Regulator-Ready Workflow

Combine reproducible methods with controlled automation:

• Protocol and scope: Pre-record clinical questions, inclusion/exclusion criteria, databases and exact search strings.
• Reproducible SLR: Capture search timestamps and export PRISMA outputs.
• Structured extraction: Populate a standardized data dictionary that includes fields required for benefit-risk analysis.
• Customizable verification: Configure a multiple reviewer workflow for confirmation for screening and sign-off on critical extracted fields (endpoints, harms).
• Traceability and updates: Auto-populate the matrix, identify gaps and record PMCF progress.

This balances efficiency with the level of human review needed for regulatory defensibility.

Practical Benefits and Operational Gains

Using a platform that integrates search, extraction, traceability and review delivers measurable advantages. Automation reduces time spent on repetitive tasks, while structured extraction cuts transcription errors; versioned audit logs and PRISMA outputs improve readiness for NB review. For example, when a Notified Body requests clarification on a performance claim, teams using a living matrix can rapidly cite exact studies, provide extracted data points and show linked PMCF activities already in progress. Rather than reassembling documents, teams can provide a concise package that includes evidence extracts, appropriate references and a documented update timeline — often closing the query with minimal iterations. Another example is Integrating Real-world evidence RWE and Decentralized Data. Real-world data, registries and decentralized trial outputs are increasingly used to strengthen CERs. Harmonizing heterogeneous sources requires careful tracking, analytical validation and reviewer verification before incorporation into benefit-risk conclusions. Platforms that tag metadata and preserve source lineage make these integrations auditable and regulator friendly.

Paired with managed services, this approach shortens project ramp-up and makes costs predictable, enabling more efficient resourcing and a clearer total cost of ownership.

Governance and Team Readiness

As seen above, there are a lot of advantages to integrate automation. However, tools are effective only with the right controls: It is also imperative that the following is considered

• Establish SOPs that specify which AI-assisted fields need mandatory human verification.
• Train reviewers to verify source information and resolve uncertain inclusions.
• Maintain strict version control and exportable logs for each CER revision.
• Update the traceability matrix with the RMF and PMS outputs on a scheduled basis.

These governance measures can help to reduce errors during an external review and can make lifecycle updates easier.

How CAPTIS^® Helps in Practice

CAPTIS^® combines integrated literature search, structured extraction and an embedded citation manager, enabling teams to reduce manual effort while preserving auditability. The platform’s version control and role-based review workflows shorten cycles and help avoid oversight. Paired with managed expertise, this delivers faster ramp-up on projects — supporting both operational efficiency and stronger submission outcomes.

Conclusion

Partnering with Celegence provides you access to skilled and experienced regulatory consultants, AI-driven solutions, and access to tailored support to streamline your CER process. From navigating complex regulations to conducting systematic literature reviews, our specialists ensure your CERs are compliant with EU MDR requirements, enabling faster regulatory approvals and confident market entry.

Are you facing challenges with your Clinical Evaluation Reports? Contact Celegence today to learn how we can help you navigate the complexities of CER preparation and ensure regulatory success.