Training Features

EU MDR 2017/745 Essentials: Understanding the Basics

Join our training to gain a solid foundation in EU MDR 2017/745, covering key requirements, classification rules, and compliance responsibilities for medical devices.
Format

Virtual Training

Level

Basic

Date

14 and 20 July 2026

Time

15:00 - 18:00 CET

Duration

2 x 3 hours

Trainer

Gert Bos

Certificate

Certificate included

Price

€ 895 or equivalent currency

Training on EU MDR 2017/745: Essential Requirements and Responsibilities

Compared to previous directives, the Medical Device Regulation (MDR) 2017/745 introduces stricter requirements for medical devices to enhance patient safety, transparency, and market surveillance. It impacts manufacturers, authorized representatives, importers, distributors, manufacturers of custom-made devices, and assemblers of systems and procedure packs, requiring a thorough understanding of compliance obligations.

Led by Gert Bos, this interactive training helps professionals gain a solid foundation in the MDR. This course covers essential requirements, classification rules, conformity assessment procedures, and key responsibilities under the regulation. Participants will receive a certificate upon completion, confirming their understanding of the MDR framework.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
The Medical Device Regulation (MDR) 2017/745 introduces stricter requirements than previous directives to strengthen patient safety, transparency, and market surveillance. It affects all economic operators, including manufacturers, authorized representatives, importers, distributors, custom-made device manufacturers, and assemblers of systems and procedure packs, making a thorough understanding of compliance obligations essential.

Qserve’s training provides professionals with a comprehensive foundation in the MDR. Participants will learn about the regulatory framework, device classification rules, conformity assessment routes, and the roles and responsibilities of economic operators. The course also covers technical documentation, clinical evaluation, post-market surveillance, vigilance requirements, and quality management system expectations.

By the end of the training, attendees will be equipped with practical knowledge to navigate MDR compliance effectively and will receive a certificate confirming their understanding of the MDR framework.
Key Learning Objectives
  • Understand the background and purpose of the MDR, including key changes from the MDD. 
  • Learn the new classification system and how it impacts different medical devices. 
  • Gain insight into the roles and responsibilities of manufacturers, authorized representatives, importers, and distributors under the MDR. 
  • Understand the conformity assessment routes and the role of Notified Bodies. 
  • Learn the essential requirements for technical documentation and clinical evaluation. 
  • Understand how to implement and maintain an MDR-compliant Quality Management System (QMS). 
  • Gain knowledge on post-market surveillance (PMS) and vigilance requirements, including incident reporting and trend analysis. 
  • Learn how to ensure ongoing compliance with regulatory requirements throughout the device lifecycle. 
  • Understand the economic and legal implications of MDR non-compliance. 
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered in two sessions, lasting 3 hours each, providing a focused and efficient learning experience. The sessions will take place on 14 and 20 July 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If this training date is not suitable, an additional session will be held in on 10 and 16 February 2026. More information can be found on the registration page.
Who Should Attend?
  • Regulatory Affairs professionals involved in MDR compliance 
  • Quality Assurance managers and directors 
  • Manufacturers, authorized representatives, importers, and distributors of medical devices 
  • Professionals responsible for technical documentation and clinical evaluation 
  • Individuals involved in post-market surveillance (PMS) and vigilance activities 
  • Anyone seeking a foundational understanding of the MDR and its impact on medical device regulations.
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Regulatory Framework & Background: Overview of MDR versus MDD, legislative structure and timelines, and the role of Notified Bodies and Competent Authorities.
  • Scope & Classification of Medical Devices: Rule-based risk classification, impact on manufacturers and portfolios, and examples of classifications.
  • Conformity Assessment & Notified Bodies: Assessment routes, certification role of Notified Bodies, and requirements for clinical evaluation and performance data.
  • Roles & Responsibilities of Economic Operators: Obligations of all actors in the supply chain, compliance and liability aspects, and post-market responsibilities.
  • Technical Documentation & Clinical Evaluation: GSPR, MDR-compliant documentation, clinical evaluation and PMCF, plus PSUR and SSCP requirements.
  • Quality Management System (QMS) Requirements: Implementation of MDR-compliant QMS, integration with ISO 13485, and ongoing compliance monitoring.
  • Post-Market Surveillance (PMS) & Vigilance: PMS planning and reporting, vigilance and incident requirements, and FSCAs with regulatory reporting.
  • Economic and Legal Considerations: Liability implications, market access strategies, and consequences of non-compliance.

Flexible Online Training Designed for MedTech Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
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

Learn directly from regulatory experts with practical industry experience and gain clear, actionable insights into navigating x.

Expert-Led Training for Practical Compliance

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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