This seminar will help you to meet the requirements of the EU regulation with minimal effort.

Goals

After the transition periods have expired, all manufacturers, distributors, EU authorized representatives and importers of medical devices must meet the requirements of the MDR.

As part of this training, you will learn which requirements you and your company need to know, understand and meet.

Content of the seminar

  • The most important innovations at a glance
    You get a quick overview of the topics that you need to address when converting to the MDR.
  • New concepts and actors
    The MDR introduces new roles such as the “Economic Actors”, the “Medical Device Coordination Group”, the “Expert Panels” and the “Person Responsible for Regulatory Compliance”. You will also learn to understand new concepts such as the " Common Specifications " and the relevance of the harmonized standards.
  • Classification and conformity assessment procedures
    You know the new classification rules that have changed for manufacturers of standalone software, for example, and you learn which conformity assessment procedures the MDR offers you and how they differ from those of the MDD.
  • Basic safety and performance requirements
    The scope of Annex I of the MDD with the "essential requirements" has multiplied. Learn to understand which new requirements you have to adapt to and how you have to prove these requirements with the help of the technical documentation , to which the MDR now dedicates a separate appendix.
  • UDI, EUDAMED, registration
    One of the most well-known changes to the MDR is the requirement for a clear identification of the products and the storage of this UDI and much other information in the EUDAMED. You will learn how you, even as a manufacturer of stand-alone software, can meet these requirements.
  • Post-Market Surveillance PMS, Post-Market Clinical Follow-Up PMCF, Clinical Evaluation
    The requirements for clinical evaluation, "clinical follow-up" and market surveillance can hardly be compared with those of MDD. You get an overview of the requirements, the required plans for the PMS and PMCF as well as the reports, in particular the "Clinical Evaluation Report", the "Post-Market Surveillance Report" and the "Perodic Safety Update Report". On request, the new requirements for clinical testing will also be presented.

This seminar not only provides you with comprehensive knowledge, but also with the skills to revise your quality management system, in particular your processes and specification documents, in order to develop MDR-compliant medical devices, place them on the market and monitor them there. This 1-day variant of the seminar primarily addresses the differences to the old EU directives.

Here you will find further information on the next dates, costs and registration. If nothing else is noted in the table on the overview page, there are still places available.

KONTAKT:
Online Seminar

 

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