Webinar: EU New Medical Device and IVD regulations
Giovanni, the Director of Operations at RegDesk, introduces a webinar focused on new medical device and in vitro diagnostic (IVD) regulations. RegDesk aids companies in navigating global regulations, enabling faster market entry and compliance.
Dr. Christian Huyghe, a Belgian expert with over 30 years in the life sciences, is featured. He emphasizes that the new regulations represent a significant evolution rather than a complete overhaul of existing directives.
Key points include:
Regulatory Changes: The new regulations will enforce stricter marketing controls and require manufacturers to reassess their products for compliance.
Cost Implications: Businesses will face increased costs related to clinical trials, quality management systems, and compliance responsibilities.
Notified Bodies: Stricter oversight of notified bodies will ensure better compliance and safety standards, with potential impacts on existing CE marks.
Device Classification: Significant changes in classification schemes will occur, affecting many devices, especially those with diagnostic functions. Software used for therapeutic decisions may be reclassified based on its risk.
Clinical Evidence Requirements: Enhanced requirements for clinical evidence, including post-market studies and the need for a designated sponsor for clinical trials, will be mandated.
Dr. Huygens notes that these updates aim to improve safety and efficacy in medical devices and diagnostics, reflecting lessons learned from past issues in the industry.