EU IVDR 2017/746 - the new EU regulation for invitro diagnostic

Attend this webinar to understand the new requirements of the medical devices regulation EU IVDR 2017/746 in the European Union and get ready to receive the new certificates until May 2022.

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Last Recorded Date: Apr-2020

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Why Should You Attend:

The new in vitro diagnostic medical devices regulation EU IVDR 2017/746 in the European Union has a lot of new requirements. This new upcoming regulation 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 action is required. Without the new certificates your sales activities in Europe are interrupted.

Learning Objectives:
  • Introduction, who must apply the new EU MDR 2017/746 requirements?
  • Overview about the changes of the EU MDR 2017/746 regarding quality management
  • What are the interfaces between the EN ISO 13485:2016 and the EU IVDR 2017/746
  • Which new requirements of the EU IVDR 2017/746 are not covered by the EN ISO 13485:2016?
  • Smart and fast ways to implement the changes in your quality management system
  • Fast track internal audit to approve the changes
Areas Covered in the Webinar:
  • The new scope of the EU IVDR 2017/746
  • The obligations and roles of the EU IVDR 2017/746
  • How work the regulation and the EN ISO 13485:2016 together?
  • New and updated processes required by the EU IVDR 2017/746
  • How to implement the required changes until May 2022?
Who Will Benefit:

CEO’s, product manager, quality/ regulatory / medical affairs manager, quality representatives of

  • IVD manufacturers
  • IVD importers
  • IVD distributors and
  • IVD dealers

who work with European Union

Instructor Profile:
Frank Stein Frank Stein

Senior Expert Medical Devices, Frank Stein healthcare projects

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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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