This platform is for educational purposes only. Content should not be considered as legal or regulatory advice.

MDR/IVDR Learning

MDR/IVDR Compliance Learning Platform

A comprehensive educational resource for healthcare workers transitioning to EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746 compliance.

Start Learning

Learning Modules

1

Introduction to MDR 745/2021 and IVDR 746/2017

Understand the regulatory framework that governs medical devices and in-vitro diagnostics in the European Union.

2

Key Changes from MDD to MDR

Explore the significant changes introduced by the new regulations compared to the previous directives.

3

Device Classification

Understand how medical devices and IVDs are classified under the new risk-based systems.

4

Roles and Responsibilities

Learn about the responsibilities of manufacturers, importers, distributors, and healthcare institutions.

5

Clinical Evaluation and Performance Studies

Deep dive into the requirements for clinical evidence and performance evaluation.

6

Post-Market Surveillance

Learn about ongoing obligations for monitoring device safety after market placement.

Who Is This Platform For?

Acute Hospital Staff

Clinical engineers, biomedical technicians, procurement officers, and clinical staff working with medical devices in hospital settings.

  • Medical device management teams
  • Operating theatre staff
  • Radiology and diagnostics departments
  • Risk management and quality teams

Community Healthcare

Staff in primary care, community diagnostics, home care services, and outpatient facilities working with IVDs and medical equipment.

  • Primary care clinical staff
  • Laboratory professionals
  • Home care equipment managers
  • Community nursing teams

About This Platform

This learning platform has been developed by experienced medical device management professionals to support healthcare workers across the European Union in understanding and implementing the requirements of the Medical Device Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746.

The content is designed to be practical and relevant to the daily responsibilities of healthcare staff who work with medical devices, whether in procurement, clinical use, maintenance, or risk management.

Each module combines regulatory explanation with real-world examples and case studies from acute hospital and community healthcare settings, helping you understand not just what the regulations require, but how to implement compliance in your own organisation.