Technical Documentation
The technical documentation is the comprehensive compilation of all documents that demonstrate the conformity of a medical device with the requirements of the EU MDR. Its content is described in detail in EU MDR Annex II and III and includes, among other elements, the product description, intended purpose, design and manufacturing information, general safety and performance requirements, risk management, clinical evaluation, labelling, and instructions for use. It must be kept up to date throughout the entire lifecycle of the product.
The instructions for use and their translations are part of the technical documentation. Changes to the IFU – including updates to translations – must be documented and evaluated as part of change management.
Frequently Asked Questions
Are IFU translations part of the technical documentation?+
Yes, the instructions for use are an integral part of the technical documentation as specified in EU MDR Annex II Section 6. The Notified Body expects the technical documentation to contain evidence of translation processes and translator qualifications. The language versions of the IFU must be managed as controlled documents within the quality management system.