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.