Today the EU Commission’s proposal has been formally published. Regulation (EU) 2024/1860 is available here.
The regulation introduces the following changes:
The amending regulation technically enters into force immediately. However, 1) the requirements for manufacturers to report potential supply disruptions shall only apply from 10 January 2025, and 2) EUDAMED will only be mandatory once published in the Official Journal of the EU.
The Commission published a webinar (and PPT) on the MDR/IVDR, geared toward international regulators. It is available here.
It covers topics such as: 1) MDR/IVDR transitional periods; 2) how manufacturers can verify their compliance for legacy devices; 3) list of MDCG guidance supporting the transition; and 4) the targeted evaluation of the MDR/IVDR, including impact to patient care, burdens on small-to-medium sized companies, and innovation.
The full IVDR extension timelines can be found here. These include the deadlines for manufacturers to implement an IVDR-compliant QMS, lodge an application with a Notified Body, and sign an agreement with a Notified body.
The extension is only related to legacy devices, i.e., those with valid IVDD CE Marking as outlined under IVDR Article 110. The extension allows those products to remain on the market for a longer period while manufacturers work toward IVDR compliance.
The IVDR extension is not:
Similar to the MDR extension, the EU Commission is expected to release clarifying details for manufacturers transitioning to the IVDR under the new extension periods.
Instead of requiring all six EUDAMED modules to be fully functional before EUDAMED becomes mandatory, the amended legislation allows for each module to become mandatory at separate intervals.
The Commission will soon publish a Q&A guide on the gradual roll-out of EUDAMED.
Steps for mandatory use:
NOTE: In principle, all custom-made devices, except Class III implantable, are excluded from EUDAMED registration requirements. Instead, custom-made devices require registration with each national Competent Authority, on a case-by-case basis. However, in some situations, custom-made devices will still need to be registered in EUDAMED, e.g., in order to report a serious incident or to submit a trend report.
The UDI/device registration module. Those with an extensive number of UDI-DIs will have significant involvement to enter their data into EUDAMED, even with machine-to-machine upload. Therefore, it is highly recommended to begin registering now, under the voluntary system. This is to better ensure you meet the registration deadline once the publication in the OJEU occurs.
A fuller overview of the new requirement to notify of potential supply disruptions can be found here.
Effective Date: 10 January 2025
Unknowns: How and where to report supply disruptions, and definitions for terms such as “interruption of supply of a device”, “reasonably foreseeable”, and “serious harm or risk of serious harm to patients or public health”.
The Commission will publish a Q&A guide on this requirement. In the meantime, the French Competent Authority (ANSM) issued updates on the process to report disruption in France.
This applies to all medical devices and IVDs, except custom-made devices.