$347 — Premium Tier

EU MDR Technical Documentation Toolkit: Annex II + GSPR Templates

EU MDR Technical Documentation Toolkit: Annex II + GSPR Templates - complete templates for EU MDR compliance.

Get the Toolkit — $347

7-day money-back guarantee • One-time purchase • Instant download

What's Included

EU MDR Technical Documentation Structure Template (Annex II)
General Safety and Performance Requirements (GSPR) Checklist
Technical File Index and Document Map
QMS Documentation Map for EU MDR (ISO 13485 + Annex IX)
Notified Body Submission Checklist
Summary of Safety and Clinical Performance (SSCP) Template

Benefits

Complete Annex II technical documentation structure
GSPR checklist covers all 23 general requirements
Notified body submission checklist reduces deficiency queries
SSCP template pre-formatted for EUDAMED upload

Is This For You?

This toolkit is designed for teams facing these challenges:

Notified body queries delaying CE marking
Technical documentation structure missing required elements
No GSPR compliance matrix
SSCP template missing or incomplete

Who This Is For

RA managers preparing EU MDR technical documentationCompanies transitioning from MDD to EU MDRNotified body submission teamsStartups pursuing CE marking for the first time

Frequently Asked Questions

Is this aligned with EU MDR 2017/745?

Yes, fully aligned with EU MDR Annex II technical documentation requirements and Annex I GSPR.

What format are the documents?

All documents are editable Word/Markdown templates ready for direct use.

Related Toolkits

Clinical Evaluation (CER)

$297

Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $347

7-day money-back guarantee