End of EU IVDR transition period — Class B IVDs and Class A sterile IVDs
Key Date
2027-05-26 — End of EU IVDR transition period — Class B IVDs and Class A sterile IVDs
Under the extended IVDR transition provisions, Class B IVDs and Class A sterile IVDs must obtain IVDR conformity assessment by 26 May 2027. Class B IVDs require involvement of a designated IVDR Notified Body for their quality management system; Class A sterile IVDs require NB involvement for sterility aspects.
IVD manufacturers in these classes should already be actively engaged with an IVDR-designated Notified Body. The number of designated IVDR Notified Bodies remains limited — manufacturers without an active NB application should treat this as a critical path item and initiate contact immediately.
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