Under the MDR, the content is set out in Annexes II and III: the device description and specification, the information supplied with the device, design and manufacturing information, the general safety and performance requirements checklist, benefit-risk analysis, product verification and validation, and post-market surveillance documentation. It has to be kept up to date, and notified bodies assess it for most devices.
Why it matters for labeling
The labels, packaging and instructions for use are part of the technical documentation, in every language the device is sold in. What is printed has to match what is in the file. A label change can mean the file needs updating, and some changes need notified body review before they are made.
Common mistakes
- Printed labels that differ from the versions in the file
- IFU versions in the file that are out of date
- Language versions missing from the documentation
- Changes made to the label without updating the file
Sources
Related reading
GUIDE
Medical Device Labeling Requirements: FDA, EU MDR, UDI, and IFU Explained
EU MDR, FDA, UDI, IFU, and ISO 15223-1 requirements for medical device labels — what teams need to verify before every release.
Read the guide →
ARTICLE
What EU MDR Actually Means for Your Device Label — And What Teams Keep Missing
Discover the critical labeling changes under EU MDR that medical device teams often overlook, ensuring compliance and avoiding costly audit findings.
Read the article →