In May 2017, the EU In-Vitro Diagnostics Regulations (IVDR) was published in the official journal of the EU, setting in motion a mandatory need to transition to the new, updated regulations. The existing IVDR comprises 10 chapters, 113 articles, and 15 annexes. The biggest change is the introduction of a risk-based approach to classification in combination with increased Notified Body oversight. The new regulation identifies four risk classes: Class A (lowest risk), Class B, Class C, and Class D (highest risk). Class B, C, and D IVDs will require Notifying Body intervention as part of their conformity assessment. The regulation mandates implementation of Unique Device Identification (UDI) to facilitate device traceability.
Here is a snapshot of the difference between IVDD (pre-approval approach) and IVDR (lifecycle approach). Given the complexities involved in IVDR implementation and the deadline to comply by May 2022, IVD manufacturers should start planning for the transition sooner rather than later. Cyient can work with you to ensure timely compliance with the new regulation.