Today, 26 May 2026, marks an important deadline for manufacturers of legacy Class C IVDs under the IVDR. To maintain access to the EU market under the extended transitional provisions (legacy devices), a formal application to a notified body must be submitted by 26 May 2026.
Legacy status for Class C IVDs
The requirements for legacy devices classified as Class C under the IVDR are:
- IVDR-compliant Quality Management System in place by 26 May 2025.
- Applying with a notified body by 26 May 2026. This applies for devices that did not require a Certificate under the Directive (IVDD).
- Having a signed agreement with a notified body by 26 September 2026. This applies for devices that did not require a Certificate under the Directive (IVDD).
- Only for manufacturers of a device covered by a Directive’s (IVDD) Certificate: the Certificate must be 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 signed an Agreement by 26 September 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).
Additionally, manufacturers of legacy devices have to meet the general legacy provisions as well:
- Devices do not present an unacceptable risk to the health or safety of patients.
- No significant changes in the design and intended purpose of the devices.
- Manufacturer is compliant with IVDD and the legacy requirements set in the IVDR.
If these requirements are met, legacy devices classified as Class C under the IVDR can remain on the market until the following dates:
- 31 December 2028 for class C devices which did not require the involvement of a notified body under the IVDD.
- 31 December 2027 for class C devices which require the involvement of a notified body under the IVDR.
If you have questions, contact us here or at mdlaw@obelis.net.
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