The In Vitro Diagnostic Regulation (IVDR) is a regulation for in vitro diagnostic (IVD) medical devices, replacing the In Vitro Diagnostic Directive (IVDD) in the European Union (EU). The IVDR was published in 2017 and became applicable on May 26, 2022.
The IVDR sets out the requirements that IVD medical device manufacturers must comply with in order to place their products on the EU market. It aims to increase the quality, safety, and reliability of IVD medical devices, as well as to enhance transparency and traceability throughout the supply chain.
The IVDR places greater emphasis on clinical evidence, and requires manufacturers to provide a clinical performance evaluation report for their IVD devices. The regulation also includes stricter requirements for notified bodies that conduct conformity assessments, and requires them to undergo regular surveillance audits.