What Must Appear on Your Device Label: MDR Section 23.2 Requirements

The label is not a summary — it is a legal document

Under EU MDR, your device label carries a defined set of mandatory items that are enumerated in Annex I Section 23.2. The list is longer than many manufacturers expect coming from MDD practice, and it is not a rough guide — each item is either present and correct, or it is a non-conformity. Notified Bodies and market surveillance authorities check labels against this list. Getting it wrong has direct consequences: a label that does not meet Section 23.2 is grounds for corrective action, and depending on severity, for market withdrawal.

The most common mistake teams make is treating label updates as a cosmetic exercise — adjusting formatting or adding the UDI barcode — without running a systematic check against the full Section 23.2 list. If your label was designed to MDD requirements, it is almost certain to be missing something. The two areas that catch most teams off guard are: the expanded requirements for specific device types, and the way the regulation links label content to EUDAMED data registration.

The core mandatory items

Every device label — regardless of class or type — must carry at minimum: the name or trade name of the device; the details necessary to identify the device and its contents (including the device model or type reference); the basic UDI-DI in both human-readable and machine-readable form; the manufacturer's name, registered trade name or registered trademark, and registered place of business; the address of the manufacturer; any special storage or handling conditions; any warnings or precautions; the manufacturing date (and expiry date where relevant); the batch number or serial number (or both, depending on your UDI assignment); and, for sterile devices, an indication of sterile condition and the method of sterilisation.

The UDI-DI requirement is where a large number of MDD-era labels need updating regardless of other content changes. The basic UDI-DI must appear on the label as a AIDC (automatic identification and data capture) carrier — a barcode or 2D data matrix — plus in a human-readable format next to it. If your label currently carries a barcode for internal lot tracking but not a UDI-compliant barcode registered in EUDAMED, you need to address both the label and the EUDAMED record.

What gets added for specific device types

Section 23.2 expands the mandatory list for several categories of devices, and this is where the MDD-to-MDR gap is most pronounced.

Sterile devices must indicate the word "STERILE" (or the ISO 7000-1051 symbol), identify the sterilisation method, and give the date of sterilisation or the lot number from which sterility can be traced. If your sterile device label uses an older symbolic notation not in ISO 15223 without an IFU reference, that needs correcting.

Implantable devices must carry an implant symbol (ISO 7000-1051) and identify the device as an implant. Additionally, the label needs to reference the implant card — which MDR introduces as a new requirement in Article 18. Teams transitioning implantable devices often discover this late, because the implant card requirement is not in the label section but it links directly to what must appear on the label.

Devices with a measuring function must include details of the measurement function sufficient for the user to understand the measurement range and accuracy. This is more specific than many MDD labels provided.

Devices containing or incorporating a medicinal substance — including human blood or plasma derivatives — must carry the name and quantity of the substance. For devices that trigger a pharmacovigilance obligation under the medicinal product legislation, the label also needs to carry the information required under that legislation.

Devices containing CMR substances or endocrine disruptors: Section 23.2(w) requires a warning statement where applicable. This is new relative to MDD and is missed on almost all legacy labels.

The EUDAMED linkage

One thing that changes labelling from a standalone exercise to a connected compliance activity is the relationship between label content and EUDAMED data. The basic UDI-DI on your label must match the UDI-DI registered in EUDAMED, and the EUDAMED record must include a number of the same data fields that appear on the label — device name, storage conditions, sterility status, single use indicator, and others.

This means a label update is not complete until EUDAMED is updated to match, and an EUDAMED update that changes a registered field may require a label change. If your regulatory team and your labelling team are operating independently, this linkage creates a risk of divergence between what is on the physical label and what is registered in EUDAMED. Both need to be synchronised before your MDR certificate is in place.

Running your label audit

The practical approach is to build a Section 23.2 compliance matrix for each label variant you have in use — one column for each mandatory item, one row for each label. Work through the list systematically rather than doing a visual check. Include the device-type-specific requirements in your matrix even for items you think do not apply — document why they do not apply rather than leaving them blank. This record is what you show a Notified Body auditor when they ask how you verified label compliance.

If your label is managed by a supplier or contract manufacturer, confirm who owns the label master and who is responsible for ensuring Section 23.2 compliance after a regulatory change. Under MDR, compliance responsibility lies with the legal manufacturer — not the supplier. A label that passes its own supplier's check but has not been reviewed against the full Section 23.2 list is still your non-conformity.