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MDR/IVDR Learning

Practical Implementation Support

Resources & Tools Hub

Everything you need to implement MDR/IVDR compliance in your healthcare facility - workflows, tools, templates, and department-specific guidance.

Implementation Workflows

Step-by-step guides for common compliance tasks including device procurement, incident reporting, FSCA response, and in-house manufacturing.

  • • Device Procurement Workflow
  • • Incident Reporting Process
  • • FSCA Response Procedure
  • • In-House Manufacturing Assessment

View Workflows →

Interactive Tools

Decision aids and calculators to support compliance decisions - classification checker, reporting timeline calculator, and UDI validator.

  • • MDR/IVDR Classification Checker
  • • Vigilance Timeline Calculator
  • • UDI Structure Validator

Use Tools →

Documentation Templates

Ready-to-use, printable forms for device acceptance, incident reporting, FSCA tracking, and training records.

  • • Device Acceptance Record
  • • Incident Report Form
  • • FSCA Tracking Form
  • • Device Register & Training Records

Get Templates →

Quick Reference Cards

Printable one-pagers for clinical areas - incident reporting, classification overview, FSCA checklist, vigilance timelines, and UDI.

  • • Incident Reporting Quick Ref
  • • Classification Overview
  • • FSCA Response Checklist
  • • Vigilance Timelines

View Cards →

Department-Specific Guides

Tailored guidance for different clinical areas with department-specific device categories and considerations.

  • • Pharmacy
  • • Radiology & Medical Imaging
  • • Laboratory & Pathology
  • • Cardiology, Theatre, Community

View Guides →

Learning Modules

Comprehensive educational content covering all aspects of MDR and IVDR compliance for healthcare workers.

  • • Introduction to MDR/IVDR
  • • Key Changes from MDD
  • • Classification & Roles
  • • Clinical Evaluation & PMS

Start Learning →

Key Terms Glossary

MDR
Medical Devices Regulation (EU) 2017/745
IVDR
In Vitro Diagnostic Regulation (EU) 2017/746
UDI
Unique Device Identifier - system for device traceability
EUDAMED
European Database on Medical Devices
FSCA
Field Safety Corrective Action
FSN
Field Safety Notice
PMS
Post-Market Surveillance
PMCF
Post-Market Clinical Follow-up
CER
Clinical Evaluation Report
PSUR
Periodic Safety Update Report
Notified Body
Independent organisation designated to assess conformity
PRRC
Person Responsible for Regulatory Compliance

External Resources

EU Regulations

  • • MDR 2017/745 Full Text
  • • IVDR 2017/746 Full Text
  • • MDCG Guidance Documents

Databases

  • • EUDAMED
  • • NANDO (Notified Bodies)
  • • GS1 GTIN Database

Competent Authorities

  • • National CA Directory
  • • Vigilance Reporting Portals

Professional Bodies

  • • COCIR (Imaging)
  • • MedTech Europe
  • • EDMA (IVD)
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