EU MDR Changes: What the Revision Means for Device Labels

The EU is revising the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). In December 2025, the European Commission proposed a "targeted revision" of both, aimed at reducing the regulatory burden while keeping patient safety standards. It amends the regulations rather than replacing them, and it isn't law yet.

Most coverage of the proposal focuses on notified bodies, clinical evidence, and fast-track pathways for breakthrough devices. This article looks at what the EU MDR changes mean for labels, Instructions for Use, and UDI.

Where Things Stand

Last updated: November 2026

The Commission published its proposal, COM(2025) 1023, on December 16, 2025, followed by a public feedback period. The European Parliament began its work in July 2026, when the lead rapporteur presented his draft report, and members tabled hundreds of amendments. The public health committee is scheduled to vote on December 3. The Council is aiming to agree its position by the end of 2026, and Parliament aims to adopt its position in early 2027. After that, the two institutions negotiate a final text.

So the final content, and when it applies, won't be known for some time. What's clear is the direction.

Meanwhile, current deadlines still apply. EUDAMED's UDI and device registration module became mandatory on May 28, 2026. Devices first placed on the market before that date that are still being sold must be registered within twelve months of the Commission's notice, so by November 27, 2026 at the latest. Some sources give November 28, so treat the 27th as your cut-off. Key MDR transition periods, including for Class III devices, end in December 2027. None of these wait for the revision.

What the Revision Changes for Labels and IFUs

eIFU for more IVDs. Under the current IVDR, electronic instructions for use are generally not available for near-patient tests. The proposal removes that exception, so professional-use near-patient tests could carry electronic IFU. For devices under the MDR, the eIFU rules stay as they are today, under Commission Implementing Regulation (EU) 2021/2226.

Digital labeling elements. The proposal allows more labeling information to be provided digitally, under defined conditions and implementing rules still to be written. The details matter: which information can move to digital, for which devices, and how users will access it.

Combination packs. For a device used exclusively with a medicine and packaged together with it, the proposal would let the device's IFU be included in the medicine's co-packaging. The device label could also be limited to a few particulars, if the medicines authority agrees and the information for safe use is in the medicine's summary of product characteristics or package leaflet. That ties the device label to the medicine's own labeling. See EU Pharma Package: What Changes for Labels and Promotion for the medicines side.

Digital documents and communication. The EU declaration of conformity can be issued digitally, and communications required under the MDR and IVDR are to happen electronically, connected to EUDAMED.

Website availability. The current text says the information supplied with a device must also be available on the manufacturer's website if it has one. The proposal drops that wording. For online sales, it adds a requirement to provide essential identification information and the IFU.

What it means in practice: for years to come, many device labels and IFUs will exist in both printed and electronic form, often varying by device type and market. Every revision will need to reach both, consistently. The eIFU and paper IFU for the same device need to match, and both need to match the approved source. We walk through what goes wrong when IFU versions drift apart in The IFU Error That Started With One Character.

What the Revision Changes for UDI and EUDAMED

Basic UDI-DI earlier in the process. Where applicable, the Basic UDI-DI would be assigned before submission to the notified body.

UDI data is public. The core data elements are to be accessible to the public, and they include label-derived fields such as storage conditions, sterile and single-use status, the manufacturer's and authorized representative's details as shown on the label, and the IFU or its web address. That makes any mismatch between what's on the label and what's registered in EUDAMED visible to regulators, to customers, and to anyone checking.

Proportionality for some devices. The proposal adjusts UDI requirements for small-volume and individualized devices, and includes preferential conditions for smaller companies.

What it means in practice: the revision reinforces the direction set by EUDAMED. UDI is treated as structured, registered data, so the label, the packaging levels, and the database record all have to agree. Our UDI Labeling Requirements guide covers where that consistency most often breaks down.

What Doesn't Change

The revision is targeted, not a rewrite. The structure of the labeling requirements in MDR Annex I, Chapter III stays in place, along with language requirements and symbols. But the proposal does edit what must appear in a few places: it deletes one label particular in Section 23.2 and reworks several IVDR label and IFU items. Our Medical Device Labeling Requirements guide covers the current requirements, which remain the basis for every label you produce today.

What Device Teams Can Do Now

The final text will take time, but device teams can prepare without waiting for it:

Get your UDI and EUDAMED data in order. Registration for devices already on the market is due November 27, 2026, and UDI data is public, so mismatches can be seen. Check that labels at every packaging level match what's registered.

Plan for print and electronic IFUs side by side. Identify which devices might qualify for eIFU, including professional-use near-patient IVDs, and set up a process that keeps paper and electronic versions in sync. Our Document Version Control guide covers how.

Co-packed with a medicine? Watch the co-packaging provision, and keep the device label aligned with the medicine's summary of product characteristics and package leaflet.

Map where digital labeling could apply. List the labeling elements that are hardest to fit on small devices or packaging, since those are likely candidates once implementing rules are published.

Track the milestones. Watch for the Council's position (expected end of 2026), Parliament's committee vote (scheduled December 3) and its first-reading position (expected early 2027). We'll update this article as the text moves forward.

For a practical pre-release check, use our Medical Device Labeling Audit Readiness Checklist.

Frequently Asked Questions

What are the EU MDR changes?They're a proposed targeted revision of the MDR and IVDR, published by the European Commission in December 2025. For labeling, the main changes are digital labels under future implementing rules, electronic IFU for more IVDs, and adjustments to UDI.

Does the revision replace the MDR?No. It amends specific articles of the MDR and IVDR. The regulations and their core requirements stay in place.

When will the MDR revision apply?Not yet decided. The proposal is still being negotiated by the European Parliament and the Council, and the timing of application will depend on the final text.

Will paper IFUs be abolished?No. The proposal extends electronic IFU to professional-use near-patient IVDs, and paper IFUs remain for many devices and users.

Content Compare verifies device labels, IFUs, and UDI carriers against the approved source across every packaging level, language, and format, printed or electronic. See how it works on your own labeling.