UK MDR Technical Documentation & Gap Assessment
A registration record does not replace the technical evidence supporting the product. The manufacturer must maintain documentation demonstrating that the device meets the applicable regulatory requirements under the route being used to access Great Britain.
Tracing the Regulatory Story Across the Dossier
We do not review documents in isolation. We trace the complete regulatory narrative across every section of your technical file:
Intended Purpose
Classification
Risk Analysis
Requirements
V&V Testing
Clinical / PER Evidence
Labeling & IFU
PMS Feedback
18 Key Technical File Review Areas
Gap Assessment Deliverables & Remediation Roadmap
Coherent Evidence Over Presence of Documents
If the intended purpose, risk analysis, testing evidence and labeling describe different versions of the product or make unsupported claims, the file is not technically robust even if every document is present. We ensure complete cross-file consistency.
UKCA Conformity Routes
UK MDR 2002 Part II: Medical devices (Annex II, IV, V, VI routes)
UK MDR 2002 Part III: Active implantable medical devices
UK MDR 2002 Part IV: In vitro diagnostic medical devices
Audit Your Technical File
Have our regulatory engineers review your dossier against UK Approved Body expectations.
Schedule Technical AuditConstruct an Unassailable Technical File for UK Market Authorization
Our regulatory dossier specialists map Essential Requirements, clinical evidence, and risk management into a unified file.