‘swissdamed’ Device Registration Module
2 July 2024Requirement to Report Supply Disruptions
17 July 2024Regulation 2024/1860 formally extends the Article 110 transitional provisions in the IVDR.
The extension allows qualifying legacy devices* to remain on the market for a longer period. Certain conditions apply and deadlines vary depending on risk classification.
Regulation 2024/1860 also amends the MDR and IVDR to require:
- Advance notice regarding potential disruption of critical products.
- Use of EUDAMED as each individual module is published in the Official Journal of the EU (as opposed to all six modules requiring full functionality and released at the same time). The first modules are expected to become mandatory January 2026.
*Devices that 1) held Notified Body issued IVDD CE Marking certificates on 26 May 2022, or 2) held valid IVDD CE Marking as self-certified on 26 May 2022, but were up-classed under the IVDR. Devices which are self-certified under both the IVDD and IVDR are not eligible. These devices should have transitioned to IVDR CE Marking by 26 May 2022.