On 25 May 2017, the new EU regulation on in vitro diagnostics (IVDR) came into force with a transitional period of 5 years and will be fully applicable from 26 May 2022. Take the chance and inform yourself free of charge and clarify your questions with experts!
The IVDR poses great challenges for manufacturers of in vitro diagnostics. It is strongly recommended that companies deal with the changes and implement the new requirements at an early stage. Both new and existing products on the market must be re-certified according to the IVDR. The implementation of the new regulation is time consuming and associated with and high costs. Important changes include the risk classification of products, stricter requirements for clinical evaluation and for post-market surveillance of in vitro diagnostics. The IVDR will also affect the cooperation between Original Equipment Manufacturer (OEM) and Private Label Manufacturer (PLM).
08:50 Login & Digital Networking
09:20 Welcome Words BIOPRO Baden-Württemberg GmbH
09:30 Michael Maier, Medidee Services AG "IVDR classification & lessons learned from the MDR transition"
10:00 Robyn Meurant, NSF Health Sciences Limited "The extent of clinical evidence required for conformity assessment"
10:30 Dr. Sebastian Grömminger, Johner Institut GmbH "Qualification and Classification of IVD-Software under IVDR"
11:00 Q&A Expert Session with Medidee Services AG, Johner Institut GmbH & NSF International
12:15 Lunch Break
13:00 PD Dr. Micha Nuebling, Paul-Ehrlich-Institut "Expectations from the Paul-Ehrlich-Institut, vision on evaluation of class D IVD"
13:40 Dr. Silvia Anghel, Medidee Services AG "Transition to IVDR: compliance, tactics and business cases"
14:10 Sabine Ohse, mdc medical device certification GmbH "The View of a Notified Body: Maintenance of IVDD Certificates during the Transition Period"
14:50 Get together & Questions
Registration is closed.