EU MDR Technical File Template

Description

Stop guessing what the Notified Body wants. Our EU MDR Technical File Template provides a fully compliant structure (Annex II & III) with ready-to-use Word templates for key documents.

What's Included?

• Folder Structure: Nested folders for GSPR, Risk Management, Clinical Evaluation, and PMS.
• Key Templates:
  • General Safety and Performance Requirements (GSPR) Checklist
  • Clinical Evaluation Plan (CEP)
  • Post-Market Surveillance (PMS) Plan
• Guidance Notes: Embedded comments explaining exactly what to write in each section.

Compatibility

• Microsoft Word (.docx)
• Google Docs
• Polarion (Import ready)