Navigating the In Vitro Diagnostic Regulation (IVDR) Rollout for Legacy & New Devices - Webinar

Celegence (https://www.celegence.com/services/ivdr/) is a global life science consulting firm focused solely on regulatory and quality compliance. We have the expertise to provide support for all of your In Vitro Diagnostic (IVD) regulatory needs; from strategic consulting, registration, device classification, PERs, to in country representation. While the industry has been preparing for some time, the next few months will be critical for the May 2022 date of application. Manufacturers of legacy devices will have to be keenly aware of how the IVDR will affect their plans and processes. The labelling requirements for the Unique Device Identifiers (UDI) are a significant hurdle on their own, as UKCA marking will also play a role for companies with a strong European presence outside of the EU. Join us to examine the technical documentation specifications with special attention to legacy devices, the labelling requirements, and what to consider when managing an RA team working towards IVDR compliance. Celegence is entrusted by 3 of the Top 10 leading Life Science companies to support their regulatory initiatives and provide strategic guidance. We have expertise and know-how to navigate the complex regulations on a global scale, supporting all stages and risk classifications. Our size allows us greater flexibility in working to accommodate our clients as quickly as possible in order to meet impending deadlines. We work as an extension of your regulatory team, filling in gaps as needed, or providing the full suite of support by completing the entire scope of work required for market approval.