About
This presentation provides an overview of the essential regulatory roles critical for medical device market access in key regions, focusing on the UK-Responsible Person (UKRP), EU Authorized Representative (EU-Rep), Swiss-Representative, and US-Agent. Each role's specific responsibilities and regulatory obligations will be explored within the context of regional compliance frameworks, including the UK MDR, EU MDR/IVDR, Swiss Medical Devices Ordinance, and FDA regulations. The session will highlight the challenges and the implications for global market strategies. Attendees will gain insights into the strategic coordination required to manage these roles effectively, ensuring seamless product registration, adherence to regional standards, and ongoing compliance. The presentation will offer a comparative perspective on these regulatory positions, emphasizing their criticality in facilitating global market access and maintaining regulatory compliance across diverse jurisdictions.

