Medical Device Regulation MDR

 

Kein Seminartermin
There is currently no known date for this seminar. Please try again at a later date or contact us.

Targets

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

During this training you will learn which requirements you and your company need to know, understand and fulfill.

Seminar contents

  • An overview of the most important innovations
    Get a quick overview over the topics you need to address when implementing the MDR.
  • New Concepts and Actors
    The MDR introduces new roles such as the "economic operators", 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 "Common Specifications" and the relevance of harmonized standards.
  • Classification and conformity assessment procedures
    You will know the new classification rules that have changed, e.g. for
    manufacturers of standalone software, and learn which conformity assessment procedures the MDR offers you and how they differ from those of the MDD.
  • General Safety and Performance Requirements
    The scope of the MDD's Annex I of "essential requirements" has multiplied. Learn to understand what new requirements you need to be prepared for and how to demonstrate these requirements using technical documentation, to which the MDR now devotes a separate annex.
  • UDI, EUDAMED, Registration
    One of the most well-known changes in the MDR is the requirement for unique identification of products and the storage of this UDI and much more 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" as well as market surveillance can hardly be compared to those of the MDD. You will get an overview of the requirements for it, required plans for PMS and PMCF as well as reports especially the "Clinical Evaluation Report", the "Post-Market Surveillance Report" and the "Perodic Safety Update Report". Upon request, the new clinical trial requirements will also be presented.

This seminar thus provides you not only 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 medical devices in conformity with MDR, to bring them to market and to monitor them there. This 1-day version of the seminar also focuses on the differences to the old EU directives. If you would like an even more comprehensive overview, we recommend our 2-day variant with a large practical part.

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

Content

Time Topic focus
09:00 Beginning of the seminar
09:00 Expectations, introduction
09:30 Background, regulatory map, changes at a glance
10:00 Actors and roles
10:30 Break
10:45 Classification and conformity assessment
11:30 Safety and performance requirements, technical documentation, “common specifications” and harmonized standards
12:30 Lunch
13:30 UDI, EUDAMED, Registration
14:15 Post-Market Clinical Follow-Up (PMCF), clinical evaluation, clinical trial (upon request).
15:00 Break
15:15 Post-Market Surveillance PMS, Vigilance
16:00 Quality management
16:30 Other, open questions
17:15 End of the seminar

We limit the number to a maximum of 16 participants to ensure learning success and to have enough time to answer individual questions.

Target group

The seminar is intended for persons involved in the development of medical devices in compliance with standards, in particular for 

  • Regulatory Affairs Managers
  • Quality Managers
  • Project Managers
  • Managing Directors
  • Development managers, developers

The seminar is also suitable for beginners and people who "only" want to get an overview of MDR. However, depending on the expectations of the participants, the seminar leader will address the specific questions in detail.

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