FDA labeling is governed primarily by 21 CFR Part 801 and device-specific rules under Title 21, while EU labelling is governed by MDR Annex I Chapter III §23. The two regimes overlap on identifying information (manufacturer, lot, expiry, UDI) and diverge on prescription statements, the Rx only symbol, language rules, and symbol recognition. A single label can serve both markets if it is designed that way from the start — but retrofitting usually costs more than doing it right once.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • FDA labeling sits under 21 CFR Part 801 and device-type-specific regulations; MDR labelling sits under Annex I Chapter III §23 of Regulation (EU) 2017/745.
  • Both regimes require identification of the manufacturer, device identifier, lot or serial number, and expiry or manufacturing date where applicable.
  • UDI requirements exist in both regimes but use different issuing agencies and database targets (GUDID in the US, Eudamed in the EU).
  • The FDA "Rx only" statement has no direct MDR equivalent; the MDR relies on intended user information and symbols per EN ISO 15223-1.
  • Language requirements differ sharply: FDA generally expects English; MDR requires the official language(s) of each Member State where the device is placed on the market.
  • A single-label strategy is possible for simple devices, but software, sterile, and implantable devices almost always need two variants.

Why this matters

Label non-conformities are one of the most common audit findings across both FDA inspections and Notified Body audits. They are also among the easiest to fix — and the most painful when they trigger a field action, because a relabelling recall is almost always visible to customers and distributors.

Startups targeting both the US and EU often assume they can design a single label that "covers both." Sometimes they can. Often they cannot, because the two regulators ask similar questions in different languages, using different symbol libraries, and with different expectations about who reads the label. Treating labelling as a translation exercise is the mistake. Treating it as two related-but-distinct regulatory outputs from a shared content source is the move.

Tibor has reviewed hundreds of device labels in audits. The recurring pattern: the content is there, but it is arranged for one jurisdiction and squeezed to fit the other. A clean dual-market label starts from a content matrix, not from a layout.

What the regulations actually say

MDR side. Annex I Chapter III §23 of Regulation (EU) 2017/745 sets out the information that shall be supplied with the device. §23.2 lists the information on the label: manufacturer name and registered place of business, UDI carrier, device identification and intended purpose where not obvious, lot or serial number, expiry date where relevant, special storage or handling conditions, warnings, indication of single use where applicable, indication of sterile state and sterilisation method where applicable, and so on. §23.4 covers the instructions for use content. Language is governed by Member State rules — most Member States require their official language for information provided to the user or patient.

FDA side. 21 CFR Part 801 is the general device labeling regulation. It establishes the basic identification requirements (name and place of business of the manufacturer, packer, or distributor under §801.1), the adequate directions for use requirement (§801.5), the prescription device exemption and the "Rx only" statement (§801.109 — which allows the symbol statement in lieu of the older full caution), and misbranding prohibitions. Device-type-specific rules add more: hearing aids, condoms, ozone-generating devices, and others have their own labeling sections. UDI is in 21 CFR Part 801 Subpart B and Part 830.

What both require. Identity of the manufacturer. A unique device identifier. Traceability data (lot, batch, or serial). Expiry or manufacturing information where the device has a defined lifetime. Warnings and contraindications where safety relevant. Adequate information for the intended user to use the device safely.

Where they diverge. The MDR is explicit that information may be provided in the form of internationally recognised symbols, and references EN ISO 15223-1 as the symbol standard. The FDA accepts symbols under 21 CFR §801.15(c) when accompanied by a symbols glossary, though it has recognised a growing list of standalone symbols over the past decade. The FDA wants "Rx only"; the MDR does not have a direct equivalent statement — the professional-use indication is handled through intended purpose, intended user, and IFU content. The FDA expects English; the MDR expects whatever official language the destination Member State requires, which for a pan-EU launch can mean 24 languages.

A worked example

A startup has a Class IIa reusable electromechanical device — a handheld diagnostic sensor. They want to launch in Germany, Austria, France, and the United States.

Their first label draft had the CE mark, Notified Body number, manufacturer address in Graz, UDI carrier (GS1), lot number, manufacturing date, and a German-French IFU reference. It was compliant on the MDR side. For the US, they tried to "add" the Rx only symbol, the FDA establishment info, and English IFU text.

The problems the label review surfaced:

  1. The UDI carrier on the EU label was an HIBCC-issued basic UDI-DI (because the startup's EU consultant defaulted to it). The US version needed a GS1 UDI in GUDID format. Those are different identifiers, not the same code in different databases. The startup had to choose one issuing agency per market or carry two codes.
  2. The German and French text pushed the symbol block into the corner; on the US-bound variant, the Rx only symbol and manufacturer US agent information needed space that the EU layout did not reserve.
  3. The symbols for "do not use if package damaged" and "consult instructions for use" were EN ISO 15223-1 compliant and also FDA-recognised — no duplication needed. Those were free wins.
  4. The expiry date format was European (DD/MM/YYYY). The FDA does not mandate a specific format but strongly prefers ISO 8601 (YYYY-MM-DD) to eliminate ambiguity. The team switched to ISO 8601 across both markets.

Final decision: two label layouts, one content source of truth, shared symbol library, dual UDI where the markets were both served by a single pack, and a production workflow that printed the correct variant from the ERP system based on destination market code.

This is not more expensive once you treat it as a system. It is much more expensive if you retrofit.

The Subtract to Ship playbook

You do not need a fifty-page labelling SOP. You need a content matrix and a decision rule.

Step 1 — Build a single content source. List every piece of information that could appear on a label or in an IFU. For each, note: required by MDR Annex I Ch III §23? Required by 21 CFR Part 801? Required by device-type rules? Recommended best practice? This becomes your dual-market content matrix.

Step 2 — Decide one-label or two-label. For simple, non-sterile, non-software devices, one physical label variant with both regulators' required content often works. For anything involving sterile packaging, prescription status, or Member State language mosaics, assume two variants.

Step 3 — Choose your UDI issuing agency strategically. GS1 is accepted by both the FDA and MDR. HIBCC is accepted by both but is common mostly in the US hospital supply chain. If you use GS1 from the start and register in both GUDID and Eudamed, you avoid carrying two barcodes.

Step 4 — Standardise on EN ISO 15223-1 symbols. Most of them are FDA-recognised. Using the symbol reduces text, reduces translation burden, and is pre-approved in the EU. Where the symbol is not FDA-recognised, include a glossary per 21 CFR §801.15(c).

Step 5 — Lock the Rx only placement early. Decide once whether your US variant carries the Rx only statement on the primary label or on the outer carton only. Document the decision in the technical file.

Step 6 — Print on demand. Modern label printers can switch variants based on a single SKU-plus-destination attribute. Design your production step to query destination, not to stockpile twenty label variants.

Step 7 — Include labelling in change control. Any change to intended purpose, warnings, or classification must trigger a label review across both markets. This is a QMS link, not a one-off.

The subtraction move here: do not create a separate FDA labelling SOP and a separate MDR labelling SOP. Create one labelling control procedure that references both regulators' requirements from the same content matrix.

Reality Check

  1. Can you point to a single document that lists every piece of information on your label and where each requirement comes from (MDR article, CFR section, standard, or internal choice)?
  2. If a Member State authority asked you to justify the language on your label, can you show which Member States you sell into and which language each requires?
  3. Have you chosen one UDI issuing agency for both markets, or are you carrying two barcodes because nobody made the call?
  4. Does your label layout reserve space for the Rx only statement on the US variant, or was it retrofitted?
  5. Are your symbols EN ISO 15223-1 compliant, and do you have a symbols glossary in your IFU for any symbol that is not FDA-recognised?
  6. Is your expiry date format ISO 8601 (YYYY-MM-DD) or something ambiguous?
  7. Does a label change trigger a review of the technical documentation and the US labeling file automatically, or is it a manual hand-off?
  8. If you had to relabel 5,000 units tomorrow because of a minor change, do you know how long it would take and what it would cost?

Frequently Asked Questions

Do I need the CE mark on my US variant? No, and you generally should not include it. The CE mark is meaningful only in the EU and adjacent regulatory regimes. On a US-only label, it adds no information and can confuse hospital procurement teams who do not understand what it means in that context.

Does the FDA accept MDR-compliant symbols? The FDA has recognised a growing list of symbols from EN ISO 15223-1 as standalone labelling elements. For any symbol not on the recognised list, 21 CFR §801.15(c) still allows use provided a symbols glossary accompanies the device. In practice, using the ISO symbol set and including a glossary covers both markets cleanly.

Can I print an IFU only in English if I sell in Germany and France? No. Member States set their own language requirements for information supplied to the user. Germany and France both require local language IFUs for devices used by patients and lay users, and typically for professional-use devices as well. English-only IFUs are not compliant for most EU launches.

Is the Rx only symbol mandatory on prescription devices in the US? 21 CFR §801.109 requires a caution statement on prescription devices. The "Rx only" symbol form is permitted as an equivalent statement.

Do I need a separate labeling file for the FDA? You do not need a separate physical file, but you do need labelling evidence in your 510(k) or PMA submission and in your Device Master Record under 21 CFR §820.181. Structure it as a section of your technical documentation that maps to both jurisdictions.

What about electronic IFUs (eIFU)? Both regimes allow eIFUs under specific conditions. In the EU, Commission Implementing Regulation (EU) 2021/2226, as amended by (EU) 2025/1234, sets the conditions. In the US, 21 CFR §801.109 allows IFUs to be provided in alternative formats under specific conditions for devices intended for use only by health professionals. The conditions are not identical — check each before assuming eIFU coverage is symmetric.

Sources

  1. Regulation (EU) 2017/745 on medical devices, consolidated text. Annex I Chapter III §23 (information supplied with the device).
  2. 21 CFR Part 801 — Labeling (general device labeling regulation, FDA).
  3. 21 CFR Part 830 — Unique Device Identification.
  4. EN ISO 15223-1 — Medical devices — Symbols to be used with information to be supplied by the manufacturer.
  5. Commission Implementing Regulation (EU) 2021/2226 as amended by (EU) 2025/1234 — Electronic instructions for use.