In May of 2022 a paradigm shift emerged in how In-Vitro Diagnostics (IVD’s) will be developed, managed, and regulated in the European Union (EU). The EU Commission (CE) has developed new regulations named the In Vitro Diagnostic Regulation (IVDR) to replace the previous In Vitro Diagnostic Directive (IVDD). The main goal of the IVDR is to improve upon the quality, safety, and reliability of IVD’s within the European market. This will change the current status quo as IVDR has been predicted to have a significant impact in medical device organizations with IVD sale and business operations.

In this whitepaper, we will provide:

• An overview of the new regulation
• Discussion some specific topics
• Considerations for organizations as they adapt to this new paradigm