In-Vitro-Diagnostics Regulation (IVDR) Inside-Out

Training on demand

IVD - Dispositivi Medico Diagnostici In Vitro / Regolatorio

In-Vitro-Diagnostics Regulation (IVDR) Inside-Out

Introduzione

The In Vitro Diagnostic Regulation (IVDR) date of application is fast approaching.

The EU Commission has just presented its amendment proposal, which is currently being discussed in the EU Council and the EU Parliament. Manufacturers still have a grace period to complete and update their technical documentation to meet notified bodies expectations and to comply with the Regulation before the Application date in May 2022.
A challenging deadline to meet regulatory requirements! That’s why through this course, we would like to transfer our first experiences and lessons learnt, so that you can benefit from the experience of sound colleagues in the field.

Join this 4-hour course to hear from Dr. Sascha Wettmarshausen, Head of Regulatory Affairs at VDGH e.V. (German IVD-Association) and from Stefanie Giesener Head of Quality Management & Regulatory Affairs at DiaSys Diagnostic Systems GmbH, talk about IVDR lessons learned so far, as well as tips and advice in the discussion with the speakers on how not to be overwhelmed by this new regulation.

IVDD/ IVDR what is new & state of play of the transition
Clinical evidence: the basics
What should a manufacturer now do?
Contracts and communication with Notified Bodies
Technical files
Class specific particularities
Case study/ full conformity assessment of a class C device/Near patient test

Medical device and IVD companies, IVD designers, manufacturers, Clinical Project Managers, Quality Management, Regulatory Affairs and/or Vigilance responsible.

Participant experience
No previous knowledge of the IVDR 2017/746 is needed. Knowledge of the IVD Directive would be helpful.

Frontal training with discussions and Q&As

Docente/i

Stefanie Giesener

Info

Stefanie Giesener

Head of Quality Management & Regulatory Affairs at DiaSys Diagnostic Systems GmbH, Germany

Stefanie Giesener has continuously worked for various companies in the medical device industry in the field of quality management and regulatory affairs since 1995. Since 2009, she is Head of Quality Management & Regulatory Affairs at the German IVD manufacturer DiaSys Diagnostic Systems GmbH. Beside her responsibilities in these companies, she was already engaged since 1997 in various committees in the German association of IVD manufacturers (VDGH), and in the European association (MedTech Europe) as well. In 2017 she became Member of the board at VDGH. She has already accompanied IVD manufacturers in their migration from the German Arzneimittelgesetz (AMG) to the European In vitro Diagnostic Directive (98/79/EC) and now she is responsible for the implementation of the IVDR at DiaSys.

Sascha Wettmarshausen

Info

Sascha Wettmarshausen

Head of Regulatory Affairs at VDGH e.V. (German IVD-Association)

Sascha Wettmarshausen was involved in the entire legislative process of the IVDR and in constant contact with the EU Parliament, the Council and the Commission. At the VDGH, Mr. Wettmarshausen is responsible for the entire area of regulatory affairs (7 committees and working groups) and is heavily involved with the European association Medtech Europe (MTE). At MTE he holds the position of the Vice-Chair of the Regulatory Affairs Committee and is involved in 5 further working groups. Furthermore, he was involved in various guidance documents and is in close contact with the German Notified Bodies and other stakeholders.

Durata e Informazioni utili
Quote Iscrizione

Training on demand – Contact us for more information

Versione Stampabile

Cosa saprai fare dopo il corso

Know the legislative context of IVDs performance evaluation

Understand the obligations of an IVD manufacturer

Understand the requirements for technical documentation

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform.

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

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In-Vitro-Diagnostics Regulation (IVDR) Inside-Out

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