Watch this on-demand webinar from ARC Regulatory and Pharmaxi for practical guidance on achieving clinical and regulatory performance study success under IVDR.

The session explores how to transition towards EU IVDR compliance, identify potential gaps and review key Economic Operator agreements, including European Authorised Representative arrangements. It also covers the essentials of planning, initiating and managing clinical performance studies—from realistic timelines and study start-up to stakeholder engagement, quality oversight and reliable results.