Transitioning from the European Union's previous In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) is a challenging process for manufacturers. The IVDR introduces risk-class based devices and requires more rigorous documentation, clinical evidence and post-market surveillance, ultimately to ensure the safety, effectiveness and reliability of in vitro diagnostic devices.
The IVDR subjects high- and medium-risk devices to a conformity assessment procedure involving an independent third party: a Notified Body.
This webinar aims to provide manufacturers with an overview of the activities of Notified Bodies and the conformity assessment process, and market insights, to provide them with the information they need to ensure their devices can be placed on the market and comply with the IVDR’s higher standards.
Agenda
Target Audience: This webinar is intended for in vitro diagnostic medical devices manufacturers worldwide, including corporations and SMEs, start-ups, persons responsible for regulatory compliance (PRRCs), EU authorized representatives, and regulatory affairs managers, quality managers, technical directors, R&D managers, validation managers and their teams.
Language: English
Cost: No charge
Can't make a live session? Register now and receive a complimentary recording after the live event. For further information, please contact: KNGlobalMarketing@sgs.com