With Regulation (EU) 2024/1860, the transitional periods for legacy IVDs have been extended. 26 May 2025 marks the first important deadline. By this date:
- Class D IVDs and IVDs covered by an IVDD CE Certificate must apply to a notified body for an IVDR certificate.
- All IVDs must have a Quality Management System (QMS) compliant with the In Vitro Diagnostics Regulation (IVDR)
Notified body application for certain high-risk IVDs
The new transitional period for legacy devices extends until December 2027 for Class D devices and for all IVDs covered by an IVDD CE Certificate. However, this extension applies only if the devices are part of a notified body’s application submitted by 26 May 2025 and have a QMS compliant with the regulation’s requirements.
IVDR-compliant QMS for all IVDs
26 May 2025 is also a key deadline for all classes of legacy in-vitro diagnostics medical devices. Manufacturers must set-up a QMS compliant with the IVDR. Additionally, manufacturers must verify which deadline applies to their device to submit an application with a notified body in time (26 May 2026 for Class C and 26 May 2027 for Class B and Class A sterile devices).
Actions: what manufacturer must do
Manufacturers must contact their notified body and inform them about the status of their transition. Obelis can support you with:
- Notified body application: Obelis selects the notified body for the manufacturer and applies on their behalf.
- Quality Management System: Obelis offers different tailored services to support manufacturers of medical devices and IVDs in preparing a QMS conforming with ISO 13485.
- IVDR and MDR compliance: As your authorised representative or consultant, Obelis guides manufacturers through the Regulations’ requirements.
Do you have any questions on your legacy devices?
References:
Eur-Lex (2024). Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices. Retrieved on 01/04/2025.
Simona Varrella
Regulatory Intelligence & Innovation
01.04.2025
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