MDR Technical Documentation Resources
General informational resources about MDR technical documentation and notified-body assessment workflows. This content is not legal, regulatory, or medical advice.
Published resources
- MDR Annex II and Annex III Technical Documentation Checklist
A structured overview of the documentation areas commonly associated with MDR Annex II and Annex III.
- Common MDR Documentation Gaps That Delay Technical Assessment
Learn how incomplete, inconsistent or difficult-to-trace documentation can slow technical assessment workflows.
- IVDR Technical Documentation Review: What Notified Bodies Check
A section-by-section reference to what Notified Bodies assess in IVDR technical documentation under Annex II and Annex III of Regulation (EU) 2017/746, including analytical performance, clinical evidence, stability and post-market surveillance.