EUDAPrep Information

EUDAPrep - EUDAMED submission preparation, automated. EUDAMED registration becomes mandatory on 28 May 2026 under EU MDR 2017/745. For SME manufacturers and the regulatory teams supporting them, that means hundreds of devices, fragmented product documentation, and a portal where a single misclassified field creates an irreversible record. EUDAPrep takes the manual work out of getting ready. Upload your IFUs, labels, and Declarations of Conformity. The tool extracts regulatory data, maps it to official EUDAMED enumeration codes, and generates schema-valid XML ready for bulk upload to the EC's portal. How it works Three-tier matching. Deterministic keyword lookup handles the majority of fields. Semantic matching, constrained to the official EC enumeration list, handles the rest. Anything ambiguous is flagged for human review. The tool never invents codes. Every output is validated against the EC's published XSD schema and business rules before export. What you upload to EUDAMED is what passed validation - you stay in control of every record. Built for • SME medical device manufacturers preparing portfolios of 20 to 500 devices • Regulatory affairs consultants scaling EUDAMED workstreams across multiple clients • PRRCs and Authorised Representatives carrying portfolio-wide responsibility What it changes Days of cross-referencing product docs, EUDAMED code lists, and submission forms collapse into a guided review. Submissions that used to risk silent misclassification now surface every gap and conditional rule before XML is generated. The PRRC remains responsible for the accuracy of submitted data. EUDAPrep makes that responsibility manageable at portfolio scale. eudaprep.com