26 September 2026: EU deadline for legacy class C IVDs

For manufacturers of legacy Class C IVDs that were self-declared under the EU IVDD, 26 September 2026 is one of the most important dates of the transition period. By this date, manufacturers must have signed a formal written agreement with a notified body if they wish to continue benefiting from the EU IVDR transitional provisions and keep placing their devices on the EU market until 31 December 2028.

Legacy status of Class C IVDs under the EU IVDR

This requirement follows an earlier deadline. Manufacturers needed to submit a formal application to a Notified Body by 26 May 2026. Manufacturers that fail to secure a written agreement with a Notified Body by 26 September 2026 will no longer qualify for the extended transition period under Article 110 of the IVDR.

The legacy status of Class C is valid until 31 December 2028 if:

• Device does not present an unacceptable risk to the health or safety of patients.
• No significant changes in the design and intended purpose of the device.
• The manufacturer has set up an IVDR compliant QMS by 26 May 2025 (Article 10.8 IVDR).
• The manufacturer complies with IVDD and the legacy requirements set in the IVDR.
• The manufacturer or the authorised representative has applied with a notified body by the latest 26 May 2026 (for devices that did not require a Certificate under the Directive).
• The manufacturer has signed an agreement with a notified body by 26 September 2026 (for devices that did not require a Certificate under the Directive).

For manufacturers of devices covered by a Directive’s Certificate issued under the IVDD

Only for manufacturers of devices covered by a Directive’s Certificate issued under the IVDD, the Certificate must have been valid on 9 July 2024 (publication date of the new Regulation) and the manufacturer must have applied with a notified body by 26 May 2025 as well as have signed an agreement by 26 Sept 2025. If the IVDD Certificate has expired before 9 July 2024, the manufacturer has signed an agreement with a notified body before the expiry date of the Certificate or obtained a national derogation measure (e.g., Article 54 IVDR).

Legacy status under the EU IVDR: all classes

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