Home > Regulations > EU MDR Labeling and IFU (Regulation 2017/745)

Regulation (EU) 2017/745, Annex I Chapter III (Section 23)

The EU MDR rules on labeling and instructions for use

Q: When did the EU MDR labeling rules start to apply?

From May 26, 2021, according to its consolidated text.1 Regulation (EU) 2023/607 lets certain legacy devices certified under the old directives stay on the market until December 31, 2027 or December 31, 2028, depending on risk class, subject to conditions.2

For regulatory and technical writers at device makers working out what the MDR expects on labels and instructions for use. This page covers what you need to know and ways to avoid running into issues.

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Applies across the EUMedical device

What we've seen reported

The Medical Devices Regulation (MDR), Regulation (EU) 2017/745, sets out in Annex I Chapter III what device labels and instructions for use carry, from the manufacturer's details, UDI and warnings to an indication that it is a medical device.¹

Last updated October 2026 · General information only, not legal advice. Sources.

Who it covers: Manufacturers of medical devices placed on the EU market, with duties for authorized representatives, importers and distributors, according to its text¹
Applies from: May 26, 2021¹Some legacy devices under the old directives: until December 31, 2027 or 2028, under conditions²
Region: European Union¹

What the rules cover

What the rules ask for

These are the kinds of information the MDR's Annex I Chapter III describes on device labels and in instructions for use, according to its text and the Commission's rules on electronic instructions.^1,³

Requirement	Where it applies
Device name, manufacturer and representative	The name or trade name of the device, and the manufacturer's name and address, plus the authorized representative where the maker is outside the EU.
UDI carrier	The UDI carrier on the label, under the unique device identification system in Article 27 and Annex VI.
Lot or serial number and dates	The lot or serial number, and a use-by date, or the date of manufacture where no use-by date is given.
Warnings and precautions	Warnings the user needs to know straight away, kept short on the label, with more detail in the IFU.
An indication that it is a medical device	On the label, with recognized symbols allowed in place of words under section 23.1.
Instructions for use (IFU)	Section 23.4 lists their content, from intended purpose and contraindications to residual risks.
Languages of labels and IFUs	Manufacturers: in the official Union language(s) set by the member state where the device reaches users, under Article 10(11).
Instructions in electronic form (eIFU)	An option for devices for professional users, under Implementing Regulation (EU) 2021/2226 as widened in 2025.

Where it goes wrong

Approved once. Then it drifts.

One approved set of product information ends up in many channels, markets and languages. Along the way it gets shortened, translated and reworded, and some versions end up without the warnings or details these rules require.

Approved onceIllustrative example

Heldan wound dressing label set: MD indication, UDI, lot, use-by date and warnings, in each market language

Pack · GermanyMedizinprodukt; UDI, LOT und Verfallsdatum auf dem Etikett "Medical device; UDI, lot and use-by date on the label"
Pack · PolandDriftedLabel reprinted for a new supplier; use-by date droppedUse-by date missing
eIFU page · FranceNotice d'utilisation, mises en garde incluses "Instructions for use, warnings included"
Training deck · SpainDriftedIFU summary reused; warnings section cutWarnings missing
Distributor listing · ItalyEtichetta e istruzioni in italiano, con UDI "Label and instructions in Italian, with UDI"
Product brochure · NetherlandsIntended purpose and contraindications as approved

How Arbitr helps

So how do you keep device labels and IFUs under control across every market and channel?

Read every version by hand? Or use AI to check what you publish against what you've already approved.

Check everything manually?

Too much to check. Too many channels, versions and translations to cover every market.
Drift goes unseen. Nothing tells you when a version moves away from the approved product information.
Changes mean starting over. When your rules or approved wording change, everything live has to be checked again by hand.

Let Arbitr do it for you

Scan what's live. Go through every live version, in every language, against your approved rules, and find every label and IFU that is missing a UDI, a use-by date or a warning.
See what needs attention. See each flagged version with the rule behind it, so your team decides what changes.
Check what comes next. Check everything new against what you approved, across every channel, market and language, before it goes live.

Approve once. Apply everywhere.

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FAQ

Questions about the EU MDR labeling rules

For your teams

Where do EU MDR labeling details go missing across our content?

Usually in the versions made after the master label. The MDR's Annex I describes information on the device, its packaging and in the instructions for use,¹ and we usually find gaps in:

relabeled or reprinted packs
translated IFUs and inserts
distributor and online listings
eIFU pages and downloads
training slides that quote the IFU

How do we keep translated IFUs in step with the EU MDR master?

Treat each language version as approved content with its own record, not a translation done once. Article 10(11) of the MDR ties labels and IFUs to the official languages each member state sets,¹ so a new warning in the master needs the same change in every language. Our packaging and labels page shows how teams track this.

What belongs in the record for each EU MDR label and IFU?

Keep one record per device: the approved label and IFU text, the UDI and symbols used, each language version, who approved it, and every pack, insert, listing and eIFU page it appears on. When a warning changes, that record shows where the old wording is still live.

How it applies to a specific IFU is a question for your legal adviser. Where that IFU appears across your markets and languages is a question Arbitr answers.

Who needs to know about the EU MDR labeling rules in our business?

Regulatory affairs usually owns the label, but packaging, technical writing, translation, e-commerce and distributor teams all publish parts of it. A short briefing for each, built from your own labels, helps. Great Britain rules such as UKCA marking sit alongside it, and related rules are on our product labeling hub.

About the rules

When did the EU MDR labeling rules start to apply?

From May 26, 2021, according to its consolidated text.¹ Regulation (EU) 2023/607 lets certain legacy devices certified under the old directives stay on the market until December 31, 2027 or December 31, 2028, depending on risk class, subject to conditions.²

Can EU MDR instructions for use be provided electronically?

For devices intended for professional users, under Implementing Regulation (EU) 2021/2226. Its 2025 amendment, Implementing Regulation (EU) 2025/1234, widened that option to all such devices and accessories, including legacy devices.³

Did the 2025 revision proposal change the EU MDR labeling rules?

Not as of October 2026. The Commission proposed a targeted revision of the MDR on December 16, 2025,⁴ which Mason Hayes & Curran reports would let some labeling information be given in digital form.⁵ The proposal still needs agreement from Parliament and Council.

About Arbitr

Does Arbitr give legal advice?

No. Arbitr checks content against rules your team has approved, including your legal team's reading of a regulation. What a regulation means for your business stays a question for your legal adviser.