Team Notified Body: Transfer Agreement for Surveillance of MDD/AIMDD Legacy Devices Updated
July 8, 2024
MDCG 2020-16 Rev.3: Updated IVD Classification Guidance Document
July 10, 2024Overview
Today the EU Commission’s proposal has been formally published. Regulation (EU) 2024/1860 is available here.
The regulation introduces the following changes:
- Extension to the IVDR transition period for legacy devices
- A gradual rollout of EUDAMED, which will make some registration modules mandatory early instead of all at once
- Requirement for manufacturers to report potential disruption to supply of critical products (including discontinuation)
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.
Informational Resource
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.
Extension to IVDR Transition
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:
- Applicable for any devices new to market. i.e., if you have a non-CE Marked product, and wish to obtain CE Marking, you must do so under the provisions of the IVDR.
- Applicable to devices that were self-certified under the IVDD and are also self-certified under the IVDR. These devices should have transitioned to IVDR CE Marking by 26 May 2022.
- An escape from eventual IVDR CE Marking, i.e., in order to be eligible for the extended transition period, manufacturers must show movement toward IVDR CE Marking.
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.
EUDAMED Gradual Roll-Out
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:
- Each module must first successfully pass an independent audit, verifying it is fully functional.
- User guides will be provided on machine-to-machine (M2M) use.
- Notice of mandatory use will be published in the Official Journal of the EU.
- Transition period commences. Manufacturers have:
- Twelve (12) months to enter medical device data (other than custom-made devices) into EUDAMED, and
- Six (6) months to enter IVD data into EUDAMED.
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.
Biggest impact to manufacturers?
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.
Reporting Potential Supply Disruptions
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.
