September 26, 2026, is approaching fast – a critical deadline for the continuity on the EU market of Class C legacy in vitro diagnostic Medical Devices (IVDs). Under Directive 98/79/EC (IVDD), these devices did not require Notified Body (NB) intervention (self-declaration), whereas under Regulation (EU) 2017/746 (IVDR), they require a conformity assessment by an NB. This category covers a significant share of routine diagnostics, including various tumor markers, diabetes tests, genetic tests, and prenatal screening.

To benefit from the transitional period until December 31, 2028, manufacturers must meet the cumulative conditions set out in Article 110(3d), including having signed a written agreement with the NB by September 26, 2026.

September 26 Agreement: the contractual binding

For Class C IVDs previously under self-declaration, submitting a formal application to the NB by May 26, 2026, was the first procedural requirement. The next binding milestone is signing the written agreement by September 26, 2026.

Operationally and chronologically, the steps are defined as follows:

  • By September 26, 2026 (Contractual phase): the NB is not required to have completed the technical assessment or audits, nor does the technical documentation need to be fully reviewed. The written agreement governs conformity assessment activities and can set schedules for document submission and NB assessments.
  • By December 31, 2028 (End of the transitional period): the transitional period for Class C devices previously under self-declaration expires. To continue placing the device on the market under the standard regime from January 1, 2029, manufacturers must have successfully completed the IVDR conformity assessment and obtained the relevant CE certificate.

Without a written agreement signed by September 26, 2026, manufacturers cannot benefit from the transitional period up to December 31, 2028.

Next steps toward 2028

For manufacturers meeting the contractual deadline, completing the transition requires:

  • Ensuring applicable transitional compliance: complying with IVDR provisions on Post-Market Surveillance (PMS), vigilance, market surveillance, and registration of economic operators and devices during the transitional period.
  • Undergoing QMS assessment: maintaining an IVDR-compliant Quality Management System and completing audits scheduled by the NB under the conformity assessment procedure.
  • Finalizing performance evaluation: consolidating scientific validity, analytical performance, and clinical performance (Article 56 and Annex XIII), including PMPF (Post-Market Performance Follow-up) plans and reports.
  • Achieving certification: successfully completing the IVDR conformity assessment procedure and obtaining the required certificate before the transitional period ends.

Frequently Asked Questions by manufacturers

  • Can the written agreement with the NB cover a device intended to replace a legacy device (substitute device)?

Yes. Both the formal application and the written agreement can cover a substitute device. The legacy device continues to benefit from the transitional period while the substitute undergoes IVDR conformity assessment.

  • Must the NB complete audits by September 26?

No. The deadline applies strictly to signing the written agreement. Audits and technical documentation reviews proceed according to the agreed schedule.

  • What happens in case of a change of NB?

Article 110(3f) governs the transfer of surveillance responsibilities, formalized via an agreement between the manufacturer, the incoming NB, and, where practicable, the outgoing NB.

Compliance is a planned process

Executing the written agreement is a key milestone, but it does not conclude the transition. Given the complexity of performance data requirements and NB lead times, manufacturers must plan activities toward the 2028 deadline immediately.

For a complete overview across all IVD classes and timelines, consult our article and Whitepaper.

>>> Complife supports you with regulatory consulting and training across every phase of IVDR compliance and certification.

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