What are the new rules for In-Vitro Diagnostic Industry with IVDR 2017/746?

I know that on the title the focus should be on the In Vitro Diagnostic situation but I promise that you will not regret this episode if you are on the pure Medical Device industry. Maurizio Suppo, from QARAD (Guess about the acronym? Maurizio will reveal it at the end) is really a great guest and I really enjoyed to discuss with him about the situation regarding the IVD industry but also a lot of other topics related to Medical Device in general. Here is a highlight of the topics we will discuss: ■ The urgency for IVD Industry to wake up and start engaging with the new IVDR ■ The risk if some manufacturers are out of business ■ Notified Body Situation for IVDR and MDR ■ The proposals that could be made to the European Commission in case some manufacturers are late ■ The talk that Maurizio will do at the TOPRA Symposium 2019 I know a lot of people are asking me if this is possible for the European Commission that they extend the due date. Maurizio provided his answer and I would agree that this is a great solution. ► Who is Maurizio Suppo? Maurizio Suppo obtained his Ph.D. in Molecular Biology from the University of Turin. He held executive positions at several world-renowned IVD companies and was the Director of the European Diagnostic Manufacturers Association (EDMA). Maurizio joined Qarad in 2012 and became co-owner in 2016. -------------------------------------------------------------------------------------------- ► Links ■ Maurizio Suppo Linkedin:   / maurizio-suppo-24204917   ■ QARAD website: https://qarad.com ■ Subscribe to QARAD newsletter: https://www.qarad.com/news ■ TOPRA Symposium 2019: https://www.topra.org/sym2019 ■ Episode 26 with TÜV SÜD on IVDR with Andreas Stange: https://podcast.easymedicaldevice.com... ------------------------------------------------------------------------------------------- ► Social Media to follow ■ Linkedin:   / melazzouzi   ■ Twitter:   / elazzouzim   ■ Pinterest:   / easymedicaldevice   ■ Instagram:   / easymedicaldevice   ------------------------------------------------------------------------------------------ #RegulatoryAffairs #medicaldevice #Podcast