MARACA International CEO Dr Luc Van Hove has announced he will be making a presentation regarding the in-vitro diagnostics regulation (IVDR) implementation from an in-vitro diagnostics (IVD) company perspective at the RAPS Workshop on IVDR & MDR.
Taking place from 16 May to 17 May in Brussels, Belgium, attendees will gain an understanding of the general safety and performance requirements (GSPR) changes versus the essential requirements (ER), as well as on the transition strategies for the implementation of the IVDR and the medical device regulation (MDR).
The RAPS Workshop is a key opportunity for visitors to learn the practical applications of the new EU regulatory requirements. Regulatory affairs experts will share valuable insights and unique perspectives on how to address the challenges posed by new regulations.
Sessions will include keynote speakers from the European Commission (EC), updates on the competent authority medical devices (CAMD) roadmap, and both MDR and IVDR changes related to clinical expectations, general safety and performance, technical documentation, labelling and post-market requirements.