Training Features

Regulation 2017/745
(EU MDR): Practical Implementation of Technical File Documentation

Join us on 11 and 18 November 2026 for a focused virtual training that will help you master the essentials of technical file documentation under the EU MDR.
Format

Virtual Training

Level

Intermediate

Date

11 and 18 November 2026

Time

14:00 - 18:00 CET

Duration

2 x 4 hours

Trainer

Robert Paassen

Certificate

Certificate included

Price

€ 1195 or equivalent currency

Technical File Documentation under the EU MDR

Under the Medical Device Regulation (MDR) 2017/745, manufacturers must maintain comprehensive technical documentation to demonstrate compliance. Properly structured technical files are essential for obtaining and maintaining CE marking and ensuring market access. 

Led by Robert Paassen, this interactive training helps medical device professionals understand the key requirements for technical file documentation. This course covers essential content, best practices for structuring documentation, and practical steps for implementation. Participants will receive a certificate upon completion, confirming their understanding of technical documentation requirements.

Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
A well prepared technical file is a cornerstone for demonstrating compliance under the Medical Device Regulation 2017 slash 745. Clear, complete and properly structured documentation is essential for securing and maintaining CE marking and ensuring continued market access.

This virtual training supports medical device professionals in understanding the requirements that apply to technical documentation. The session walks through the essential elements, explains how to structure information effectively, and provides practical guidance for implementation in daily practice. Participants receive a certificate after completing the course, confirming their understanding of MDR technical documentation expectations.
Key Learning Objectives
  • Understand the regulatory requirements for MDR/IVDR technical documentation 
  • Learn how to structure and maintain a compliant technical file 
  • Gain insight into clinical and performance evaluation requirements 
  • Understand the integration of risk management and usability engineering into documentation 
  • Learn about labeling, UDI, and EUDAMED compliance requirements 
  • Understand post-market surveillance and vigilance documentation needs 
  • Identify common technical file deficiencies and best practices for compliance 
  • Learn how to prepare technical documentation for Notified Body review.
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 4 hours each, providing a focused and efficient learning experience. The sessions will take place on 11 and 18 November 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If this training date is not suitable, additional sessions will be held on 20 and 28 May 2026. More information can be found on the registration page.
Who Should Attend?
  • Regulatory Affairs professionals responsible for technical documentation 
  • Quality Assurance managers and personnel 
  • R&D and product development teams 
  • Clinical and performance evaluation specialists 
  • Post-market surveillance (PMS) and vigilance professionals 
  • Anyone involved in compiling, reviewing, or maintaining MDR technical documentation.
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 requirements for technical documentation, including MDR expectations, differences between MDD and MDR, and the role of Notified Bodies. 
  • Structure of a compliant technical file, covering required sections, GSPR mapping, design and manufacturing details, verification and validation data, and Annex II and III requirements.
  • Clinical evidence needs, including clinical evaluation, clinical investigation, and PMCF.
  • Risk management and usability engineering, integrating ISO 14971, applying IEC 62366 principles, and demonstrating the risk-benefit profile.
  • Labelling and UDI requirements, including IFU expectations, UDI and EUDAMED, and language compliance.
  • Post-market surveillance and vigilance documentation, including PMS planning, SSCP, PSUR, incident reporting, and field safety actions 
  • Additional documentation for devices with medicinal substances, human or animal tissues or cells, or substance-based products 
  • Best practices and Notified Body expectations, including common gaps, preparation tips, and lifecycle maintenance of technical documentation.

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

Robert Paassen

Robert Paassen is a Regulatory Affairs & Quality Assurance consultant specializing in EU MDR, serving as a Startup Lead, with expertise in clinical evaluations, quality management system remediation, CAPA management, risk management, and supporting audits.