Training Features

MDR and IVDR 2.0: Executive Summary 

Gain a clear and practical overview of the latest updates under MDR and IVDR with our “MDR and IVDR 2.0: Executive Summary” e-learning, designed to equip busy MedTech professionals with the essential insights needed to stay compliant and confident.
Format

E-Learning

Level

Basis

Trainer

Gert Bos

Exam

Exam and certificate included

Duration

30 minutes
5 modules

Price

€ 95 or equivalent currency

From Patchwork to Predictability: EU MDR & IVDR 2.0

The EU regulatory landscape is undergoing its most significant structural shift since the inception of the MDR. As the industry moves away from a "patchwork" of endless guidances toward a more centralized, "Pharma-like" model overseen by the EMA, the stakes for compliance have never been higher. 

This training deconstructs the MDR and IVDR 2.0 proposals, providing you with the technical depth and strategic clarity required to manage the transition from 1.0 without losing market momentum.
What You Will Learn
Who Should Attend?
What is Included?
Course Details
By the end of this 30-minute training, participants will be able to: 
  • Identify the political and systemic drivers behind the transition from MDR/IVDR 1.0 to the 2.0 proposals. 
  • Distinguish between current compliance requirements (MDR and IVDR as last updated by Regulation 2024/1860) and the proposed long-term structural changes. 
  • Analyze key changes in conformity assessment, including the removal of the 5-year certification limit and reduced audit frequencies. 
  • Evaluate the impact of clinical and technical simplifications, such as the "same or similar" equivalence route for clinical, biocompatibility, and software down-classification. 
  • Plan strategic next steps for ongoing projects while the 2.0 proposal undergoes the multi-year legislative process. 
What is included in this e-learning?
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Access to any mentioned guidances or ISO standards that are not publicly available is not included in this e-learning.
  • Duration: Approx. 30-minutes.
  • Format: Self-paced e-learning (video, interactive content, and quizzes).
This training is designed for professionals in the Medical Device and In Vitro Diagnostic (IVD) industries, specifically: 
  • Regulatory Affairs (RA) & Quality Assurance (QA) Managers: To understand technical changes in conformity assessments and equivalence. 
  • Executive Management & Strategic Leads: To grasp the long-term impact on business models, certification costs, and product lifecycles. 
  • Product Developers & R&D Engineers: To learn about software classification changes and requirements for multi-use devices. 
  • Clinical Affairs Specialists: To understand the simplification of clinical burden and the new "same or similar" equivalence rules. 

Comprehensive Regulatory Expertise

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Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

We offer a flexible learning schedule, allowing professionals to balance their training with their busy work and personal lives, ensuring accessibility to a wide range of learners.

Flexible Learning Schedule

Modules

Explore the training modules available in this course

Meet the Trainer

Gert Bos

Gert has 26 years of experience in life sciences (devices and pharma), in university, industry, 4 Notified Bodies, and in strategic regulatory and business consulting.
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