On December 16, 2025, the European Commission published a long-awaited proposal aimed at simplifying the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This proposal follows the landmark Commission Decision (EU) 2025/2371 from late November, which officially triggered the clock for EUDAMED, with mandatory use beginning in May 2026.
As the new proposal has many implications for the medical device industry – which will be explored in a series of our blogs – this text focuses on the impact on UDI and EUDAMED, including other tools for information exchange.
UDI and EUDAMED | Visible changes and what they mean in practice
Some of the changes introduced by the proposal are not merely language or technical adjustments. They reshape transparency, data governance and responsibilities for Manufacturers, Notified Bodies and Competent Authorities.
A new place to record the Basic UDI-DI: Procedure Pack Statement
One notable change is the introduction of a new document where the Basic UDI-DI must be recorded: the procedure pack statement, specifically with reference to the device contents.
While intended to improve clarity and transparency, it adds to documentation complexity and management.
PRRC information no longer public
The proposal removes public access to information about the Person Responsible for Regulatory Compliance (PRRC), reducing concerns around personal data exposure.
UDI data verification by Notified Bodies for class III and IIb implantables
The new approach introduces UDI data correctness checks by Notified Bodies for class III and class IIb implantable devices. This adds another task to Notified Bodies’ responsibilities, despite NB capacity already being a recognised bottleneck. Also, the chronology of this requirement is unclear, as the UDI data has to be registered before placing devices on the market, i.e. after the Manufacturer has received their certificate.
Connection of national databases to EUDAMED
It is proposed that national distributor databases containing device-related information are enabled to retrieve that information from EUDAMED. While potentially technically challenging for some Member States, this change addresses the fragmented national-EU data landscape and hopefully limits the needed for repeated submission across EU countries.
Extended timeline for Actor registration updates
A smaller but practical change is the extension of the deadline for introducing changes to a EUDAMED-registered Economic Operator from one week to two weeks.
SSCP – review, upload and accessibility
With the proposed update of Article 32, the Commission aims to relieve Manufacturers of part of the burden associated with the Summary of Safety and Clinical Performance (SSCP): for devices that can be considered a Well-Established Technology, an SSCP is no longer required.
For devices that still need to have an SSCP, given that the draft summary is part of the documentation submitted to the Notified Body, a separate validation is not required anymore. The responsibility of SSCP upload in EUDAMED is now shifted to Manufacturers.
Changes to Article 28 and Article 32 indicate that the SSCP submitted in EUDAMED will no longer be accessible to the public, and that Manufacturers will have to indicate on their label or in the IFU how to access it.
Direct Marking exemption for single patient use devices
One of the most impactful and welcomed changes in the area of UDI is the exemption from direct marking for devices intended to be reused on the same patient. This is a major alignment with the US rules and global UDI practices and addresses the concern around disproportionate burden for single patient use devices.
Preferential conditions for micro and small enterprises
Finally, the proposal acknowledges the disproportionate financial impact that the UDI system participation can have on smaller manufacturers. It introduces a notable economic consideration by requesting UDI issuing entities to take into account the needs of micro and small enterprises.
EUDAMED – no longer alone
Another major change regarding EUDAMED is that it might not be the only database that Economic Operators will have to use in the future. With this new proposal, the Commission opens the door to other electronic systems to fulfill some roles that are not yet implemented in EUDAMED, while ensuring mutual interoperability.
Article 10a, which describes obligations regarding interruption or discontinuation of supply of certain devices, is amended to add the use of a central IT system to facilitate reporting and information exchange. It could be integrated into EUDAMED or a separate tool that is interoperable with EUDAMED. The European Medicines Agency (EMA) and the Medical Device Shortages Steering Group (MDSSG) need to work hand in hand to develop a methodology to identify and list devices that would fall within the scope of this article.
UDI and EUDAMED | Corrections, Alignment and Clarity
Beyond the headline changes to UDI and EUDAMED, the Commission’s proposal also introduces a series of more subtle amendments, addressing long-standing inconsistencies, ambiguities and interpretative gaps. These include:
Correcting the definition of Basic UDI-DI
In its original wording, the Regulations’ definition of Basic UDI-DI mixed two distinct UDI concepts: identifier allocation for the device group or family and the ‘unit of use’ concept, which belongs to a different level of the UDI hierarchy. The proposed correction realigns the Basic UDI-DI with its intended role.
Formalising UDI Requirements for Systems and Procedure Packs (Producers)
Another welcome alignment is the formal inclusion of actor registration and UDI requirements for systems/procedure packs and their producers. Until now, the affected parties mostly relied on MDCG guidance and Commission FAQ documents. The proposal embeds these expectations directly into the regulatory text.
Consistent inclusion of UDI rules for HIDs
The proposal also addresses a more consistent inclusion of UDI rules for Highly Individualised Devices (HIDs), aligning expectations across the Regulation.
Final Thoughts
The Commission’s proposal introduces some visible and impactful changes to the UDI and EUDAMED space, as well as more subtle adjustments for better clarity and consistency.
While aimed at “simplifying and reducing the burden of the rules”, the proposed changes also bring a few additional requirements for stakeholders active in the medical device sector.
It is important to note that this is still only a proposal, subject to legislative procedures before any changes become legally binding.
Stay Tuned
- This article is part of Qserve’s series on MDR and IVDR 2.0, where we’ll explore the key areas of impact and their practical application.
- Need support? From change assessments and regulatory interpretation to hands-on implementation support tailored to your organization, we help you navigate compliance with confidence.
- To help you navigate these changes, Qserve Group hosts two separate webinars: one for the MDR Update and another for the IVDR Update. Register now:
- MDR Update | Tuesday, 20th January 2026, starting at 4:00 pm CET
- IVDR Update | Thursday, 22nd January, 2026, starting at 4:00 pm CET.