On 4 June 2021, Marta Swierczynska, Senior Manager Regulatory Affairs at SFL, provided an introduction to clinical evaluation under the EU Medical Device Regulation (MDR) at the BADI conference on ‘Drug regulatory affairs’. She presented the new requirements for clinical evaluation of medical devices under the MDR and shared her practical insights for device manufacturers.

SFL’s medical device and combination products team can support companies with every aspect of the MDR/ In Vitro Diagnostics Regulation (IVDR) implementation for medical devices, combination products and in vitro diagnostics.