Labeling and IFU Requirements Under EU MDR: Complete Guide to Annex I Sections 23-24

What Are the Labeling and IFU Requirements Under EU MDR?

Labeling and IFU Requirements Under EU MDR are defined in Section 23 of Annex I of Regulation (EU) 2017/745 — specifically sub-sections 23.2 (label) and 23.4 (instructions for use). These requirements specify what information medical device manufacturers must provide on the device label, packaging, and instructions for use (IFU). Compliance with these requirements is mandatory for CE marking and is one of the most frequently cited areas of non-conformity during Notified Body audits.

The labeling and IFU requirements apply to all medical devices, regardless of risk class. The level of detail and the number of required elements increase with device complexity and risk. For an overview of the full MDR framework, read the EU MDR Compliance Complete Guide.

Regulatory Basis

Annex I Section 23.2, Information on the Label

Section 23.2 specifies information that must appear on the device label. The label must be supplied with each device unit or its packaging.

Annex I Section 23.4, Information in the Instructions for Use

Section 23.4 specifies information that must appear in the IFU. The IFU must accompany each device unit unless an exception applies.

Device Label Requirements (Section 23.2)

The label must bear all of the following information:

• Device name or trade name: As defined by the manufacturer and consistent across regulatory documentation
• Essential information: Details necessary for the user to identify the device, its intended purpose, and contents
• Manufacturer name and address: Registered business address, matching the EUDAMED actor registration
• SRN: Single Registration Number of the manufacturer (format: Country Code-MF-000000000, e.g., DE-MF-000000000)
• Authorized Representative: If the manufacturer is outside the EU (excluding countries with specific Customs Union agreements like Turkey, which do not require an AR), the AR name and address, including SRN (format XX-AR-000000000)
• UDI carrier: UDI-DI and UDI-PI on label and packaging levels per Annex VI Part C
• Batch code or serial number: Identifies the specific production batch (lot) or device serial number
• Date of manufacture: Clearly indicated as year and month
• Use-by date: For devices with an expiry date, in the format YYYY-MM-DD
• Sterilization indication: If supplied sterile, the sterilization method and sterile packaging indication
• Single use indication: If intended for single use, the symbol per ISO 15223-1
• Storage and handling conditions: Temperature range, humidity, pressure, light sensitivity
• Special operating conditions: Any warnings, precautions, or contraindications necessary for safe use
• CMR or endocrine-disrupting substances: If the device contains CMR or endocrine-disrupting substances, identification of those substances per Section 10.6
• Human blood or plasma derivative: If the device incorporates human blood or plasma derivatives, an indication of this
• Annex XVI designation: For devices without an intended medical purpose per Annex XVI, an indication that the product is a medical device

Label Format Requirements

• Language: Labels must be in the official language(s) of the member state where the device is sold
• Readability: Text must be legible, durable (resistant to environmental factors and intended processing, such as sterilization), and appropriate for the intended user (healthcare professional or lay person)
• Symbols: Standardised symbols per ISO 15223-1 may replace text where recognised

Instructions for Use Requirements (Section 23.4)

The IFU must include all information necessary for the safe and effective use of the device. The MDR requires significantly more IFU content than the MDD.

IFU Content Requirements

• Device identification: Name, model, Basic UDI-DI, manufacturer, AR, and SRN
• Intended purpose: The medical indication, target patient population, anatomical site, and intended user
• Clinical benefits: Expected clinical benefits supported by the clinical evaluation
• Contraindications: Conditions under which the device must NOT be used
• Target population: Age, gender, weight, health status, and any subpopulation restrictions
• Intended user profile: Required training, qualifications, or experience
• Device description: Operating principle, mechanism of action, materials, dimensions
• Preparation before use: Installation, calibration, assembly, or configuration steps
• Operating instructions: Step-by-step instructions for normal use
• Special warnings and precautions: Residual risks, foreseeable misuse, and mitigation measures
• Adverse events and side effects: Known adverse events, frequency, and management
• Interactions: Known interactions with medicinal products, other devices, or substances
• Accessories: Required accessories and compatible devices
• Maintenance and calibration: Required activities, frequency, and procedures
• Cleaning, disinfection, sterilisation: Reprocessing instructions for reusable devices
• Disposal: Special disposal considerations, including electronic waste, batteries, or biological contamination
• Single-use or reuse limitation: Reuse restrictions with justification
• Shelf life: Expected service life and storage conditions
• Performance characteristics: Technical specifications, accuracy, sensitivity, specificity
• Residual risks summary: Overview of residual risks from the risk management file
• IFU date of issue and revision: Publication date and version number
• Manufacturer contact: Customer support and technical assistance contact information

Exceptions to Providing IFU

For certain class I and class IIa devices, the IFU may be omitted if the device can be used safely without written instructions. This exception applies when the device’s safe use is self-evident without such instructions. (Manufacturers must justify this in their risk management file per Annex I, Section 23.1(d)).

Electronic IFU (eIFU)

The MDR permits electronic IFU (eIFU) under Regulation (EU) 2021/2226 for devices intended for professional use. eIFU requirements:

• Website availability: eIFU must be accessible on a publicly available website
• Downloadable format: PDF or equivalent printable format
• Version control: Clear version identification and revision history
• Customer notification: Users must be informed when the eIFU is updated

UDI Carrier on Labels

The UDI carrier includes both:

• UDI-DI: Device identifier (static, identifies device model)
• UDI-PI: Production identifier (dynamic, batch/serial/expiry)

Placement Requirements (Annex VI Part C)

• The UDI carrier must appear on all label levels: device label, packaging, and shipping
• For reusable devices, the UDI carrier must be directly marked on the device itself (direct marking)
• AIDC (Automatic Identification and Data Capture) format, typically barcode or QR code
• HRI (Human Readable Interpretation), plain text alongside the machine-readable code

Symbols and ISO 15223-1

The MDR encourages the use of standardised symbols to reduce language burden. ISO 15223-1 defines symbols for medical device labelling. Common ISO 15223-1 symbols include:

• Single use: Symbol for intended single use
• Use-by date: Hourglass or calendar symbol
• Batch code: Symbol for lot/batch identification
• Catalogue number: Reference number symbol
• Sterile: Methods of sterilization (EtO, radiation, steam)
• Do not reuse: Prohibition symbol
• Keep away from sunlight: Environmental protection symbol

Symbols used without accompanying text must be defined in the IFU or on the label.

Implant Card (Article 18)

For implantable devices, the manufacturer must provide an implant card with the following information:

• Device identification: Name, type, Basic UDI-DI, serial number
• Manufacturer identification: Name, address, SRN, website
• Implant information: Date of implantation, surgical site
• Patient identification: Name, date of birth, or unique patient identifier
• Warnings and precautions: Known risks, MRI compatibility, expected service life
• Contact information: Manufacturer support contact for implant-related issues

Note: Article 18 includes specific exemptions. Sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors are exempted from the implant card requirement.

Language Requirements

The MDR requires labeling and IFU in the official EU language(s) of each member state where the device is marketed. Member states specify their accepted languages in national legislation. Common requirements:

• Germany: German
• France: French
• Italy: Italian
• Spain: Spanish
• Netherlands: Dutch
• Poland: Polish
• All others: Respective national languages

Manufacturers should verify language requirements with each member state’s competent authority before market placement.

Common Labeling Non-Conformities

Notified Body label and IFU reviews consistently identify:

Missing or Incorrect SRN

The Single Registration Number must appear on the label. Many manufacturers omit the SRN or use an incorrect format.

Incomplete UDI Carrier

UDI-DI and UDI-PI must both appear on all label levels. Missing AIDC or HRI format elements are common findings.

Language Gaps

Labels and IFU not available in all required languages for the target member states. Some manufacturers provide only English IFU for non-English markets.

Insufficient IFU Content

IFU missing required elements specified in Section 23.4, particularly clinical benefits, residual risks summary, and adverse events information.

Outdated Symbols

Symbols not conforming to the latest ISO 15223-1 edition. The standard is updated periodically and manufacturers must ensure compliance.

Implant Card Missing

For implantable devices, the implant card per Article 18 is sometimes omitted or does not contain all required fields.

Summary

Labeling and IFU Requirements Under EU MDR as defined in Annex I Section 23 (particularly 23.2 and 23.4) are a critical component of conformity assessment. Key success factors include:

• Complete label content including SRN, UDI carrier, and all mandatory elements
• Comprehensive IFU content per Section 23.4 with warnings, clinical data, and residual risks
• Compliance with language requirements in each target member state
• Standardised symbols per ISO 15223-1 for international harmonisation
• Implant card per Article 18 for implantable devices
• eIFU compliance per Regulation (EU) 2021/2226

External resources:

• EUR-Lex MDR Annex I Section 23
• ISO 15223-1 Medical Device Symbols
• Regulation (EU) 2021/2226 eIFU

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