Design Dossier Updates
Maintaining current and compliant design documentation is a continuous regulatory obligation under the MDR and IVDR. For manufacturers, design dossiers and technical files must accurately reflect the current configuration, intended purpose, and risk profile of every device placed on the market. However, many organisations face challenges in keeping design documentation synchronised with design changes, post-market findings, and evolving regulatory interpretations. Uncontrolled updates, undocumented changes, or outdated justifications frequently result in non-conformities during Notified Body audits and jeopardise certificate validity.
Our Design Dossier Update services provide a structured framework for managing and executing documentation updates that ensure ongoing conformity and readiness for regulatory inspection. We begin with a diagnostic review of existing dossiers to evaluate alignment with the latest MDR or IVDR Annex II and III requirements, current MDCG guidance, and Notified Body expectations. Each document is examined for completeness, data integrity, and consistency across related files such as the risk management report, clinical evaluation, and post-market surveillance outputs.
Once the baseline is established, we develop a controlled update plan that defines the scope, sequence, and responsibilities for revising each section of the design dossier. This plan aligns with your internal change control and document management systems, ensuring that all updates follow a validated process and that version control is maintained throughout. Our consultants assist in updating device descriptions, component specifications, verification and validation data, and manufacturing process documentation to reflect the current design state.
Risk management and clinical evaluation updates form a central focus of our work. As new post-market data become available, we ensure that risk assessments are reviewed and updated accordingly, with clear traceability between identified hazards, control measures, and clinical performance data. Where new information impacts benefit-risk conclusions or labelling, we coordinate with quality and regulatory teams to update relevant documents and ensure consistency across all affected files.
We also support clients in incorporating new regulatory expectations derived from MDCG guidance, harmonised standards, and evolving Notified Body feedback. This proactive approach minimises the risk of findings during future audits or surveillance reviews. For manufacturers managing multiple product lines, we establish standardised templates and document hierarchies that promote consistency and simplify ongoing maintenance.
Our approach ensures that every update is intentional, traceable, and defensible. By integrating regulatory insight with documentation discipline, we help clients sustain certification, reduce audit risk, and uphold their commitment to quality and patient safety.
For further information on how our Design Dossier Update services can support ongoing compliance and readiness under MDR and IVDR, please contact our regulatory documentation team.
