EU MDR & IVDR Labeling & IFU Compliance

Labeling is the visible interface of your regulatory compliance. We verify product labels, primary and secondary packaging, UDI placement, sterile barriers and Instructions for Use against stringent MDR/IVDR mandates.

Audit Your Artwork & IFU

Labeling & IFU Deliverables

Annex I Chapter III Section 23 (MDR) / Section 20 (IVDR) GSPR compliance audit

ISO 15223-1 medical device symbology validation and symbol justification

UDI carrier (GS1 / HIBCC) layout, Human Readable Interpretation (HRI) and 2D DataMatrix placement

Sterile barrier system and protective packaging label distinction

Instructions for Use (IFU) authoring, risk warnings, contraindications and clinical claims alignment

Electronic Instructions for Use (eIFU) compliance under Regulation (EU) 2021/2226

National language requirement mapping across target EU member state markets

Translation governance procedures and technical accuracy verification

Expert Differentiator

100% Alignment with Risk Management and CER/PER

Warnings, contraindications, risk information and clinical claims in the Instructions for Use should be consistent with the risk management file and clinical evidence. The wording should suit the intended user while preserving the supported meaning and scope.

Multilingual Compliance

Each EU member state defines specific language requirements for user information. We provide official country-by-country translation tables to ensure compliance across all target distribution territories.

Labeling Review

Submit your packaging proofs and IFUs for comprehensive regulatory audit.

Review Packaging Proofs

Ensure Flawless Packaging, Symbology, and Multilingual IFUs

Our labeling specialists audit and align your artwork across European regulatory standards.

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