Introduction into the EU IVDR 2017/746 – the new EU regulation for invitro diagnostic medical devices: 2-Day In-Person Seminar

By: Prof. Dr. h.c. Frank Stein, Senior Medical Device Expert, Nemius Consulting GmbH
Location :- San Francisco, CA | Monday, December 16, 2019 | Tuesday, December 17, 2019

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Course Description:

This course will give an introduction into the new in vitro diagnostic medical devices regulation EU IVDR 2017/746 in the European Union. This new regulation has a lot of new requirements and is also stronger connected to the EN ISO 13485:2016. The understanding of these changes and how to implement changes until May 2022 is essential to receive the new certificates until May 2022. The first key for the understanding and the implementation of the changes is the knowledge about the new requirements for the IVD-products. The second key is to understand, which changes need the quality management system according the ISO 13485:2016, which need more processes under the new IVDR as outlined in the ISO 13485:2016. These not covered paragraphs and requirements must be additional implemented into the quality management system until May 2022. The time is short and immediately actions are required. Without the new certificates your sales activities in Europe are interrupted.

Learning Objectives:

  • What are the requirements of the new EU IVDR 2017/746?
  • Which Companies must apply the new EU IVDR 2017/746?
  • How to implement the new EU IVDR 2017/746 in a smart way into a medical device quality management system and how to apply the new regulation on your products to receive a new product certificate until May 2022?
  • How work the EU IVDR 2017/746 product reviews?
  • How work the EU IVDR 2017/745 quality management audits?

Who will Benefit:

  • CEO’s of companies, which sell in vitro diagnostic medical devices to Europe
  • Regulatory Affairs Managers of companies, which sell in vitro diagnostic medical devices to Europe
  • Quality Managers of companies, which sell in vitro diagnostic medical devices to Europe
  • Quality Representatives of companies, which sell in vitro diagnostic medical devices to Europe
  • Other managers, which need to deal with regulatory or quality guidelines

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 8:30 AM - 8:59 AM: Registration. Meet & Greet.
  • 9:00 AM -11:00 AM: Introduction into EU IVDR 2017/746 (Overview about this regulation, structure, scope)
  • 11:00 AM - 12:00 Noon: The new approach of the risk classes to classify the IVD - products
  • 12:00 Noon -1:00 PM: Lunch
  • 1:00 PM - 2:30 PM: The new approach of the conformity assessment procedure (workflow, technical documentation, clinical data, post market surveillance, post market clinical follow up)
  • 2:30 PM - 3:00 PM: Refreshments Break.
  • 3:00 PM - 4:30 PM: The new approach of the conformity assessment procedure (workflow, technical documentation, clinical data, post market surveillance, post market clinical follow up)
Day Two (8:30 AM – 4:30 PM)
  • 8:30 AM - 8:59 AM: Registration. Meet & Greet.
  • 9:00 AM -11:00 AM: How to deal with clinical data and to approve product performance and safety
  • 11:00 AM - 12:00 AM: Frequently Post – Market – Surveillance and Post Market Clinical Follow up reporting to Notified Bodies and Competent Authorities
  • 12:00 Noon -1:00 PM: Lunch
  • 1:00 PM - 2:30 PM: Reporting to authorities (incidents, field safety, corrective actions, changes)
  • 2:30 PM - 3:00 PM: What are the expectations of European Notified Bodies and Competent Authorities?

Meet Your Instructor

Frank Stein
Prof. Dr. h.c. Frank Stein
Senior Medical Device Expert, Nemius Consulting GmbH

Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.


San Francisco, CA (Venue to be announced shortly)

December 16-17, 2019
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Seminar One Registration

December 16-17, 2019, San Francisco, CA
(For Registrations till November 21, 2019 - $1699)
(For Registrations after November 21, 2019 - $1899)

Early bird seats are limited and based on first-come, first-serve.

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