Webinar series - MDR made simple

A four-episode webinar series to help medical device manufacturers navigate MDR requirements with clarity and confidence.

The EU Medical Device Regulation (MDR) sets a high bar for demonstrating the safety, performance, and compliance of medical devices. For many manufacturers, the regulation’s scope and complexity can create uncertainty and leave critical compliance gaps unaddressed.

This MDR made simple webinar series is designed to bridge that gap. Across four focused sessions, our expert will guide you through the essential elements of MDR compliance, from classification and technical documentation to clinical evaluation and QMS alignment, providing practical steps you can apply immediately on your path to CE marking.

Join us to gain clear, actionable insights into classification, documentation, clinical evaluation, and QMS, the fundamental building blocks of MDR compliance.

Agenda

MDR made simple webinar series

16 September 2025

Episode 1 – Understanding MDR structure and device classification

Start with the foundations. Understand the core structure of MDR and how to classify your devices correctly, a crucial first step towards CE compliance.

 

Date: Tuesday, 16 September 2025 

Time: 15:00 – 16:00 AEST (GMT +10) 

Agenda:

  • What CE marking means for medical devices
  • MDR vs MDD — key changes
  • Classification rules (Class I, IIa, IIb, III)
  • Conformity assessment routes and when a Notified Body is required
  • Timeline and strategic planning
  • MDR Annex VIII device classes explained
  • Practical examples to apply classification rules
  • How classification impacts clinical, technical, and regulatory obligations
14 October 2025

Episode 2 – Technical documentation under MDR

Learn what a compliant technical file must include, how to structure it effectively, and what to avoid to ensure MDR expectations are met.

 

Date: Tuesday, 14 October 2025

Time: 15:00 – 16:00 AEST (GMT +10) 

Agenda:

  • Annex II & III: Structure of the Technical File
  • Demonstrating compliance with General Safety and Performance Requirements (GSPR) – Annex I
  • Tips for creating robust design dossiers
12 November 2025

Episode 3 – Clinical evaluation and post-market planning in MDR

Gain confidence in planning and conducting clinical evaluations, and learn how to demonstrate safety and performance effectively under MDR.

 

Date: Wednesday, 12 November 2025

Time: 15:00 – 16:00 AEST (GMT +10) 

Agenda:

  • Conducting a Clinical Evaluation (Annex XIV Part A)
  • Literature review, equivalence, and PMCF (Post-Market Clinical Follow-up)
  • When full clinical investigations are needed
  • PMS plans, PSURs, trend reporting, serious incident reporting
  • Aligning with MDCG guidance documents
  • Common pitfalls to avoid
10 December 2025

Episode 4 – Building an MDR-ready QMS: What you need to know

Understand how your Quality Management System connects with MDR and what changes are essential to maintain compliance.

 

Date: Wednesday, 10 December 2025  

Time: 15:00 – 16:00 AEST (GMT +10) 

Agenda:

  • Key ISO 13485:2016 requirements
  • Integration of MDR-specific elements (e.g. UDI, vigilance, PMS)
  • Internal audits and management review
  • Preparing your QMS for ongoing compliance