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IVDR: class B / sterile class A NB written agreement

European CommissionCompliance deadline High impact in 316 days
Date
Sun 26 Sep 2027
Body
European Commission
Scope
EU
Subject
Medical devices
Official source
eur-lex.europa.eu

To keep the transition to 31 Dec 2029, manufacturers of legacy class B and sterile class A IVDs must have a signed written agreement with a notified body by this date.

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Related upcoming dates

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Sat 28 Nov 2026 · European CommissionIVDR: class B / sterile class A NB application deadline
Wed 26 May 2027 · European CommissionEUDAMED: certificate registration deadline
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Thu 02 Dec 2027 · European CommissionMDR: end of transition for class III and implantable IIb
Fri 31 Dec 2027 · European CommissionIVDR: end of transition for class D and legacy-certified IVDs
Fri 31 Dec 2027 · European Commission

Dates are taken from the official source above. Agencies occasionally reschedule; confirm on the source before acting.