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Medical Device Resources

MDR – 2017/745

Regulation (EU) 2017/745 of The European Parliament and of The Council of 5 April 2017 on Medical Devices

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IVDR – 2017/746

Regulation (EU) 2017/746 of The European Parliament and of The Council of 5 April 2017 on In Vitro Diagnostic Medical Devices

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KEY ARTICLES & ANNEXES

This document highlights the key articles and annexes relevant to Medical Device Regulations

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MDR & IVDR Guide

An introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation (IVDR)

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MDR & IVDR IMPLEMENTATION

A Simplimedica PowerPoint Presentation on MDR & IVDR Implementation

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INFOGRAPHIC GUIDE PACK

Our experts have prepared an infographic guide pack for your regulatory and compliance journey

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  • SERVICES
    • REGULATORY AND QUALITY ASSURANCE SERVICES
    • CONSULTANT ON DEMAND
    • MARKET ACCESS, REGULATORY ROADMAP & GRANT-WRITING
    • RESOURCES
    • INTENDED USE STATEMENT
  • TRAINING COURSES
  • SHOP
    • BOOK CONSULTATION
    • TEMPLATES
      • EQUIPMENT VALIDATION
      • MEDICAL DEVICES
      • PHARMACEUTICALS
  • DIGITAL HEALTHCARE
  • NEWS
  • ABOUT
    • ABOUT SIMPLIMEDICA
    • SIMPLIMEDICA PODCASTS
    • INTERNSHIPS
    • SIMPLIMEDICA ON LINKEDIN
    • SIMPLIMEDICA ON YOUTUBE
  • CONTACT