How to Prepare Technical Documentation for CE Marking

Purpose of technical documentation

Under Regulation (EU) 2017/745, manufacturers must establish and maintain documentation that enables authorities and notified bodies to understand the device, its intended purpose, design, manufacture, risks and supporting evidence.

Core sections

Device description and specification

Include product names, models, intended purpose, users, patient population, operating principle, accessories, classification rationale and identifiers such as the Basic UDI-DI.

Information supplied by the manufacturer

Labels, instructions for use, packaging information and symbols must be consistent with the device claims, clinical evaluation and risk controls.

Design, manufacturing and GSPR evidence

Document design stages, critical processes, suppliers and validations. Map each applicable General Safety and Performance Requirement to standards, methods and objective evidence.

Risk management and clinical evidence

Maintain an ISO 14971-aligned risk management file consistent with clinical evaluation, verification and validation, labelling, PMS and, where applicable, PMCF.