General MDR Documents

This collection brings together general EU MDR templates that do not belong to one specialist workstream. It includes practical starting points for regulatory strategy, device classification, technical documentation, declarations, economic-operator records, post-market activities, and other documents used across a medical-device lifecycle.

Start with the templates that match your device, risk class, conformity-assessment route, and role. Then adapt them to the MDR, applicable MDCG guidance, harmonised standards or common specifications, and your own quality system. A class I software manufacturer and a class III implant manufacturer will not need the same evidence or level of detail.

These are editable examples, not a complete technical-documentation file and not legal advice. Remove prompts that do not apply only after recording why, keep terminology and identifiers consistent across documents, and connect each record to the procedure that creates, reviews, approves, and maintains it. Your final documentation must describe the device and the work your organisation actually performed—not the example company assumed by a template.