Attestato di partecipazione
About
The In Vitro Diagnostic Regulation (IVDR) date of application is fast approaching and the EU Commission has already submitted an amending regulation for discussion in the Council and 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 requirements in terms of Clinical Evidence.
Clinical evidence must be available for all legacy devices and data can be obtained from different sources, such as, for example, clinical performance studies, scientific peer-reviewed literature, and published experience gained by routine diagnostic testing. The clinical performance studies shall be linked to the plan for post-market performance follow-up.
The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of the regulations and, in particular, the applicable general safety and performance requirements.
This means, for IVDR:
- Information on analytical performance, clinical performance, and clinical evidence according to Annex XIII of Regulation (EU) 2017/746
- Performance evaluation plan
- Scientific validity report
- Analytical performance report
- Clinical performance report
- Clinical evidence and performance evaluation report
- Draft of the summary of safety and performance
The list is not comprehensive, but just a few examples of what the regulatory requirements are. Manufacturers will need to comply with a challenging deadline to meet these regulatory requirements!
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 what clinical evidence is under the scope of the IVDR!
- Basics of the IVDR and amendments to the existing Directive
- Basics of Clinical Evidence under the IVDR scope
- Methods of demonstration
- Clinical performance report
- Clinical evidence and performance evaluation report
- Summary of safety and performance
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
Lecturers
Stefanie Giesener
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
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.
This online training consists of 1 module:
07 June 2022 from 9:00 am to 1:00 pm CEST
Some days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 495,00* (until 23 May 2022)
Ordinary: € 625,00*
Freelance – Academy – Public Administration**: € 370,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Registrati
Printable Version
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.