EU Regulation 2024/1860 includes an amendment to the MDR & IVDR regarding a gradual rollout of Eudamed modules and a subsequent change in compliance timelines for manufacturers.

Regulation (EU) 2024/1860, adopted on 13 June 2024, introduces significant updates to the European regulations governing the rollout of the Eudamed database, as well as the obligations related to the supply of medical devices and in vitro diagnostic devices.

Instead of waiting for implementation of all 6 modules to be finalized before requiring compliance, a gradual roll-out strategy will be used, with compliance required 6 months after each module is audited and published. This is intended to streamline the implementation of Eudamed and improve communication regarding the availability of medical devices and diagnostics across the EU.

Medical devices placed on the EU market will require UDI data registration in Eudamed. Medical device distributed exclusively outside the EU does not yet need to have UDI data registered in Eudamed. In the United States, the Unique Device Identification (UDI) system is regulated by the U.S. Food and Drug Administration (FDA) under the FDA UDI Rule (21 CFR 830).

The core modules of Eudamed (device registration, certificates and notified bodies information) are required to be operational by Q1 2025, with publication in Q2 of 2025. It is expected that by 1 January 2026 the additional Eudamed modules, including clinical investigations, post market surveillance and vigilance reporting will be fully integrated.

New devices placed on the market after this date will need to be registered in Eudamed as part of the initial market entry process, with a July 2026 deadline for registration of existing and legacy devices. An updated roadmap is available at the European Commission website.

However, there are practical challenges ahead for manufacturers, particularly considering the estimated 350,000 EUDAMED registrations likely represents only 10-15% of the expected registrations as the July 2026 deadline approaches. This will put the system (EU commission website, helpdesk, IT / personnel etc.) under enormous strain and could result in unexpected and costly delays for manufacturers.

It is therefore highly recommended to plan and implement your strategy for EUDAMED compliance as soon as possible and avoid being caught up in the last-minute rush of applications at the deadline. The European Commission has endorsed recommendations to register by July 2025 to avoid any unexpected delays or difficulties.

The U.S. Food and Drug Administration (FDA) has established three regulatory classes based on the level of control needed to ensure the safety and effectiveness of medical devices. If your device is categorized as Class I or Class II and not exempt from the premarket notification process, you will need to submit a 510(k) application before marketing it. For the highest risk class (class III), pre-market approval (PMA) is generally required.

You can use the FDA’s product classification database to look up a device type and find its corresponding regulation and classification, including information on whether a pre-market clinical investigation is expected or not. Pre-market clinical investigation is required for most PMA devices, but only for a minority of 510(k) devices.
All classes of device are also subject to General Controls, which are baseline requirements under the Food, Drug, and Cosmetic Act and are needed to demonstrate safety and effectiveness.

If your device requires a premarket notification, the 510(k) process is a pathway for medical device manufacturers to obtain clearance from the FDA by demonstrating substantial equivalence to existing and already legally marketed devices.  Whether clinical data are needed or not for a 510(k) submission depends on the risk classification of the device and the nature of the changes or modifications compared to the predicate device.

It is the responsibility of the applicant to compare the new device to a predicate device and provide evidence that the new device has the same intended use, and that the device is as safe and effective as the predicate device. If there are significant differences that could affect safety or effectiveness, clinical data may be necessary to support the substantial equivalence claim. For example, if the new device raises NEW questions of safety or effectiveness that cannot be resolved through non-clinical testing or if there are significant technological differences from the predicate device, additional clinical data may be required. In those cases, clinical studies may be needed to evaluate the device’s performance, safety, and usability with human subjects under real-world conditions. Manufacturers should therefore carefully assess the regulatory requirements and seek guidance from the FDA to ensure compliance with applicable regulations when preparing a 510(k) submission.

To be noted is that there are situations where clinical data might also be necessary for Class I and II devices that are exempt from premarket notification requirements. For instance, if a new Class I/II device is intended for a novel or innovative purpose, or if modifications to the device raise new questions about its safety or effectiveness, the FDA might require additional data that also include clinical studies to support its approval or clearance

The FDA provides guidance documents and regulatory requirements that outline when clinical data are necessary for a 510(k) submission. For detailed guidance see The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], Section F.

To avoid potentially costly surprises, it is recommended to not wait until submission before consulting with the FDA. It is better to approach them as early as possible to determine the appropriate regulatory pathway and data requirements for your specific device. The FDA is usually very helpful in these situations as long as you have sufficient information for them to evaluate.