Labeling and Marking Requirements under MDR – A Guide for Rollator Manufacturers

Meeting MDR (EU) 2017/745 standards goes beyond product performance. Proper labeling—including CE mark, UDI, and multilingual Instructions for Use (IFU)—is a legal obligation and essential to trust. This guide details MDR-compliant labeling best practices using RELAXSMITH ROLLATOR as a benchmark.

1. Why Labeling Compliance Matters

• Legal Enforcement: Mislabeling can lead to customs rejection, product recall, or EU market bans.
• Patient Safety: Clear labels help users operate safely, especially elderly or multilingual patients.
• Distributor Trust: Resellers and clinics require traceable, multilingual packaging to meet internal SOPs.

2. Mandatory Elements of MDR-Compliant Labels

• CE Mark: Must include the symbol “CE” and optionally the notified body number (if applicable).
• UDI (Unique Device Identifier): Includes device identifier (DI) and production identifier (PI), encoded in both text and barcode.
• Manufacturer/Importer Address: With full postal contact in EU.
• Device Name + Model No.: Matched to technical file description and UDI database.
• Date of Manufacture + Serial Number: Printed visibly near barcode for batch tracking.
• IFU Language: Must match the official language(s) of each market country—up to 24 EU languages.

3. How RELAXSMITH ROLLATOR Executes Perfect Labeling

• Design Consistency: Same label layout across cartons, user manuals, QR codes, and product frames.
• Smart QR Code: Redirects to digital IFU page in 10+ EU languages + update notices.
• Color Coding: High contrast fonts and anti-fade ink for aging users and outdoor use.

4. Common Mistakes to Avoid

• CE Mark Misuse: “China Export” logo is not valid. Use standardized CE format only.
• UDI Mismatch: Label barcode must match EUDAMED registration entry and tech file.
• Missing Translations: Even Class I IFUs must be in the native language of each sales country.

5. Templates and Tips

• Use ISO 15223-1 standard for label symbols (e.g., caution, latex-free, storage conditions)
• Label dimensions must remain legible on device or packaging
• Digital IFUs are allowed if declared, linked, and available offline if requested

6. Audit-Ready Proof with RELAXSMITH ROLLATOR

• Labels, QR codes, and IFUs stored in audit-ready folders with version logs and language indexes.
• Distributors provided PDF and printed master files to ensure consistency across EU warehouses.
• Updated labels auto-reflected in the GSPR checklist and Declaration of Conformity.