Open Training: MDR 6 years later - Lessons Learned

October 13, 2023

Training: In person

Date: 13 October 2023

Time: 9:00 - 17:00 CEST

Price: € 699,-

Location: Novotel Amsterdam Schiphol Airport | Amsterdam, the Netherlands


Although the transition is still ongoing the MDR has been already published for about six years, during which we have gained significant experience in understanding how requirements are expected to be practically applied, how member states interpret the legislation, and how to effectively handle Notified Bodies expectations. These sessions will address the main topics of the MDR presenting the most common pitfalls and how to practically prevent or overcome them. We will focus on how to make effective use of the extended transitional period and how to keep MDD files up to date while already keeping the MDR requirements in sight.

The following topics will be discussed during this workshop:

  • General Introduction
  • High-level Risk Management
  • Clinical Lessons learned
  • QMS Lessons learned
  • Technical Documentation Lessons learned
  • Biocompatibility Lessons learned
  • Q & A


Bianca Lutters, PhD
Dr. Stéphane Naudin
Robert Paassen, MSc
René Schings
Post date: July 11, 2023
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