End of EU IVDR transition period — Class B, C, D laboratory IVDs (higher scrutiny categories)
Key Date
2028-05-26 — End of EU IVDR transition period — Class B, C, D laboratory IVDs (higher scrutiny categories)
Under the extended IVDR transition timetable, Class B, C, and D IVDs requiring full IVDR Notified Body conformity assessment (NB review of technical documentation, not just QMS) must complete IVDR certification by 26 May 2028.
Class C and D IVDs carry the highest scrutiny requirements under IVDR, including performance evaluation with clinical evidence and, for Class D devices, batch release verification by an EU Reference Laboratory (EURL). Manufacturers in these categories should have active NB engagement and performance study programmes well underway before this deadline.
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