Labelling Requirements For Medical Devices In The EU MDR

The implementation of the Regulation (EU) 2017/745 commonly referred to as the EU MDR has significantly strengthened labelling, traceability, and post-market surveillance obligations for medical device manufacturers.

As regulatory scrutiny intensifies and EUDAMED functionality expands, accurate and compliant device labelling is no longer an administrative formality it is a core regulatory control mechanism. Non-compliant labelling may result in CE marking delays, notified body observations, product recalls, field safety corrective actions (FSCA), or market withdrawal.

This in-depth technical guide by Maven Regulatory Solutions outlines EU MDR labelling requirements, UDI obligations, General Safety and Performance Requirements (GSPR) alignment, electronic IFU compliance, sterile barrier labeling, and the latest regulatory updates.

Regulatory Framework Governing EU MDR Labelling

EU MDR labelling requirements are primarily defined as:

• Article 10 (General obligations of manufacturers)
• Annex I (General Safety and Performance Requirements – GSPR)
• Annex VI (Unique Device Identification – UDI system)
• Annex VII (Notified Body requirements)

Labelling must ensure:

• Device traceability
• User safety
• Risk communication
• Transparency
• Lifecycle identification

Essential Information Required on EU MDR Labels

1. Device Name and Trade Name

The label must clearly state:

• Device name
• Trade name (if applicable)
• Model or reference number
• Manufacturing date (if no expiration date is indicated)

This ensures complete product traceability and supports vigilance investigations.

2. Medical Device Identification Symbol

A standardized medical device symbol must appear on the label to clearly indicate the regulatory status of the product. Symbol usage must align with harmonized standards (e.g., ISO 15223-1).

Manufacturer and EU Authorized Representative Information

Manufacturer Details

The label must include:

• Legal manufacturer name
• Registered address
• Contact information

If the manufacturer is located outside the EU, additional clarity regarding product origin and intended use is essential.

EU Authorized Representative (EC REP)

For non-EU manufacturers, the label must display:

• Name and address of the EU Authorized Representative
• EC REP symbol

This ensures regulatory accountability within the European Economic Area (EEA).

Usage and Safety Information

Safe Use Period

Where applicable, the label must indicate:

• Expiry date (YYYY-MM format)
• Implantation deadline (if relevant)

Alerts, Warnings & Precautions

Mandatory inclusion of:

• Contraindications
• Safety precautions
• Special storage conditions
• Handling instructions
• Residual risk statements

Clear communication mitigates misuse and enhances patient safety.

Special Labelling Requirements for Class III and Implantable Devices

Under EU MDR, high-risk devices require enhanced transparency.

GSPR Checklist Reference

For Class III and implantable devices:

• Compliance with Annex I GSPR must be demonstrated
• Clinical evaluation summary required
• Safety and clinical performance summary (SSCP) must be publicly accessible via EUDAMED

Electronic Instructions for Use (eIFU)

Under specific conditions, manufacturers may provide electronic IFUs.

eIFU Requirements

• Web address must be printed on label
• Instructions must be accessible without restriction
• Backup paper copy available upon request
• Cybersecurity controls implemented

Recent enforcement trends show greater scrutiny on website accessibility and version control of IFUs.

Unique Device Identification (UDI) Requirements

UDI implementation is one of the most critical EU MDR labeling elements.

UDI Carrier Placement

UDI must appear:

• On the device label
• On packaging levels
• Directly on the device (where applicable)

UDI Structure

UDIs must be registered within the European database on medical devices EUDAMED.

Machine-Readable and Human-Readable Information

Labels must include:

• Barcode or 2D Data Matrix
• Human-readable UDI format
• Harmonized symbols

This ensures compatibility with hospital scanning systems and supply chain traceability.

Composition and Sterility Labelling

Material Composition

For absorbable or implantable devices, the label must specify:

• Qualitative composition
• Quantitative information (where necessary)
• Allergenic materials (e.g., latex presence)

Sterile Barrier Requirements

Mandatory sterile labeling elements include:

• Sterility status (Sterile / Non-Sterile)
• Sterilization method (e.g., EO, Gamma)
• Sterile barrier symbol
• Expiration date
• Instructions to consult IFU if packaging is damaged

Failure in sterile barrier labeling is a common Notified Body non-conformity observation.

CE Marking and Label Placement

The CE marking must:

• Be visible, legible, and indelible
• Include Notified Body identification number (if applicable)
• Be placed on device and packaging

Improper CE marking placement is a frequent cause of regulatory findings.

Recent EU MDR Labelling Updates 

• Increased Notified Body audits on UDI traceability
• EUDAMED module expansion and mandatory data submission
• Cybersecurity labeling requirements for software medical devices (MDR + IEC 81001 alignment)
• Language localization enforcement across EU Member States
• Enhanced scrutiny on sustainability and packaging claims

Common EU MDR Labelling Compliance Risks

Importance of Proactive Compliance

Failure to comply with EU MDR labelling obligations may lead to:

• CE certification suspension
• Product recalls
• Market access denial
• Financial penalties
• Reputational damage

A structured regulatory labeling strategy ensures audit readiness and smooth Notified Body assessments.

How Maven Regulatory Solutions Supports EU MDR Labelling Compliance

Maven Regulatory Solutions provides end-to-end EU MDR regulatory consulting including:

• MDR Annex I GSPR gap assessment
• UDI implementation strategy
• EUDAMED registration support
• Technical documentation review
• CE marking compliance advisory
• eIFU compliance validation
• Sterile barrier labeling review
• Notified Body audit preparation

Our medical device regulatory experts ensure complete EU MDR labeling compliance aligned with Regulation (EU) 2017/745 and current Notified Body expectations.

Frequently Asked Questions (FAQs)

1. Is UDI mandatory under EU MDR?

Yes. UDI implementation is mandatory for most medical devices and must be registered in EUDAMED.

2. What are GSPR requirements in labeling?

Annex I GSPR outlines safety and performance requirements that must be demonstrated within technical documentation and reflected in labeling.

3. Are electronic IFUs allowed under EU MDR?

Yes, under specific conditions and device categories, provided compliance with accessibility and version control requirements.

4. What happens if labeling is non-compliant?

Non-compliance may result in CE certification delays, Notified Body observations, or product recalls.

5. Are implantable devices subject to additional labeling rules?

Yes. Implantable devices require enhanced clinical transparency and often direct UDI marking.

Conclusion

EU MDR labelling requirements represent a critical compliance pillar in the European medical device regulatory framework. From UDI integration and GSPR alignment to sterile barrier labeling and electronic IFU accessibility, manufacturers must adopt a meticulous, risk-based approach.

With regulatory enforcement intensifying in 2026 and EUDAMED becoming fully operational, proactive labelling compliance is essential for uninterrupted CE marking and sustainable EU market access.

Maven Regulatory Solutions empowers medical device manufacturers with strategic EU MDR labeling expertise, ensuring technical precision, regulatory alignment, and long-term compliance success.