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The In Vitro Diagnostic Medical Devices Regulation (IVDR) brought significant changes compared to the previous directive (IVDD). These changes impact manufacturers, Notified Bodies, and healthcare providers. Understanding these key differences is crucial for ensuring compliance and maintaining access to the European market. One of the most significant changes is the classification of IVD devices. Under the IVDD, most IVD devices were self-certified, meaning manufacturers could declare conformity without the involvement of a Notified Body. However, under the IVDR, a risk-based classification system has been introduced, with devices classified into four classes: Class A, Class B, Class C, and Class D. Higher-risk devices now require Notified Body involvement for conformity assessment. This increased scrutiny aims to ensure the safety and performance of IVD devices, particularly those used for critical decisions in healthcare.
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