Today, 9 July 2024, Regulation (EU) 2024/1860 was listed in the Official Journal of the EU. After the Council approval on 30 May, the latest MDR and IVDR amendments apply in the European Union from today following the Journal’s publication, except for the new obligation for manufacturers to inform of supply interruptions that applies from 10 January 2025.
What changes for IVDs and medical devices manufacturers
New IVD legacy period
The new transitional period for IVDR legacy devices are:
- 31 December 2027 for Class D and devices covered by an IVDD CE Certificate
- 31 December 2028 for Class C
- 31 December 2029 for Class B and A sterile
The new legacy extension applies only if IVD manufacturers are approaching a notified body (at the latest by 26 May 2025 for Class D, by 26 May 2026 for Class C and by 26 May 2027 for Class B and Class A sterile devices), and have an IVDR-compliant QMS at the latest by 26 May 2025.
EUDAMED implementation
The new Regulation introduces a gradual EUDAMED roll-out. The first modules will become mandatory once they are available, audited, and declared functional. Probably, this will occur around the end of 2025. This means that EUDAMED will no longer have to be fully functional for registrations to specific modules (actor, device, vigilance) to be mandatory. Actor and device registration is expected to be mandatory in 2026. The law also includes the requirement for a single registration only, the EUDAMED registration, which aims to replace the single national registrations. This will not exclude compliance with other national requirements such as language requirements.
Supply interruption notification
The MDR and IVDR amendments also include measures to protect patients from supply interruptions. To prevent any market disruptions, manufacturers of medical devices and IVDs are obliged to inform at least 6 months in advance the local competent authorities and health institutions before they stop, either temporarily or permanently, to supply a critical device.
Do you want to keep placing your IVDs and medical devices on the market according to legacy requirements? Contact us now.
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