MDR Complete Bundle

MDR Complete Bundle

What it is: the complete EU MDR documentation set in one premium bundle. Three coordinated kits that cover the full pre-market and post-market lifecycle for a medical device under Regulation (EU) 2017/745: technical file (Annex II), clinical evaluation and post-market clinical follow-up, plus the full risk management file.

What is included

EU MDR Technical Documentation Kit — 8 templates:

• Device Description and Specifications
• Labelling and Instructions for Use
• Design and Manufacturing Information
• General Safety and Performance Requirements
• Benefit-Risk Analysis and Risk Management
• Product Verification and Validation
• Post-Market Surveillance
• Declaration of Conformity

EU MDR Clinical Documentation Kit — 8 templates:

• Clinical Evaluation Plan
• Clinical Evaluation Report
• Clinical Development Plan
• Post-Market Surveillance Plan
• Periodic Safety Update Report
• Post-Market Clinical Follow-up Plan
• Post-Market Clinical Follow-up Evaluation Report
• Summary of Safety and Clinical Performance

Risk Management Documentation Kit — 6 templates:

• Risk Management Plan
• Risk Management Report
• Hazard Analysis
• Design Failure Mode and Effects Analysis
• Use-related Failure Mode and Effects Analysis
• General Safety and Performance Requirements Checklist

22 templates in total: 15 Word documents + 7 Excel workbooks, plus 3 Master Index spreadsheets and 3 READMEs (one per kit), with cross-references between the three kits for full Technical ↔ Clinical ↔ Risk traceability.

Format

22 fully editable Microsoft Word and Excel files. Delivered as three ZIP archives (one per kit). Instant download after purchase.

What you save

Buying the three kits separately costs EUR 1,177 (EUR 429 + EUR 399 + EUR 349). The combined bundle is EUR 999 — you save EUR 178 (15%).