An updated timeline for the mandatory implementation and use of the European Database on Medical Devices (EUDAMED) is now available. Where the previous EUDAMED timeline showed mandatory use starting in Q2 2029, the new timeline shows the mandatory use of the Device Registration and Unique Device Identification (UDI) module starting from Q1 2026.
To help make medical device manufacturers aware of key dates and understand the requirements and regulatory implications for their businesses, Jay Crowley from USDM Life Sciences and Lionel Tussau from BAYARD co-presented in the webinar Mandatory Use of EUDAMED Now Starting Q1 2026.
The following questions were asked during the webinar.
What is the recommendation in regard to UDI EUDAMED devices that are under the Medical Device Directive (MDD) extension and the long delays to obtain Medical Device Regulation (MDR) certification? How long should a company wait to register? My company submitted technical files for review three years ago and just received the first round of questions. Though we wish to maintain a proactive approach, previous recommendations have been to wait for MDR CE marking certification.
You should not wait! Assuming you are still distributing (placing on the market) this Directive-compliant device, it is, by definition, a Legacy device. As such, its registration in EUDAMED is unrelated to the receipt of an MDR certificate. A legacy device is subject to various provisions of the MDR, including the MDR requirements related to: 1) post-market surveillance (PMS), 2) market surveillance, 3) vigilance, and 4) registration of economic operators and devices.
Moreover, these devices:
- Must continue to comply with the Directive (MDD and Active Implantable Medical Device [AIMD])
- Cannot undergo significant changes in the design or intended purpose
- Do not present an unacceptable risk to health or safety
And the manufacturer must:
- By 26 May 2024, have put in place a Quality Management System (QMS) that meets MDR Article 10(9)
- By 26 May 2024, have lodged a formal application with the Notified Body (NB)
- By 26 September 2024, have signed a written agreement with the NB
The deadline for registering these Legacy devices is around June 2026, assuming the equivalent MDR device has not been registered.
When will we get clarification about the amount of data required for Post-Market Surveillance and Vigilance (PMSV) actions on Legacy devices that also have Regulation devices?
If a Legacy device is required to be registered, even if the equivalent Regulation device is registered, then full EUDAMED registration will be necessary. This information is fully described in the UDI Devices data dictionary (the Excel file automatically downloads).
We know about initiatives at the National Health Service (NHS) forcing pharma companies to provide a Life Cycle Assessment (LCA) regarding sustainability. Will this happen for medical devices, too?
We don’t yet know, but it’s very likely.
Is AS4 (Applicability Statement 4; to securely exchange business-to-business messages between trading partners) required for an xml upload?
Yes.
Are there any concerns or challenges when attributes change and what are the implications? For example, U.S. Food and Drug Administration (FDA) UDI has its own challenges around Global Medical Device Nomenclature (GMDN) codes that become obsolete. Are there specific attributes we should be mindful of?
Since we are still operating in the EUDAMED Minimal Viable Product (MVP), I think it is too early to tell how the data attributes may evolve over time. However, I would remain hyper-vigilant about any of the EUDAMED new UDI Device Identifier (UDI-DI) triggers (of which there are many). Of those, the ones associated with the Basic UDI-DI (BUDI) are critical; a change to any of those requires a new Basic UDI-DI and any of the UDI-DIs associated with it. (A UDI-DI can be associated to only one BUDI).