Regulatory & Compliance
Labeling & IFU.
We develop MDR- and IVDR-compliant labeling strategies and instructions for use for medical device manufacturers—in multiple languages, compliant with ISO 15223, and ready for use in technical documentation.
What labeling challenges does the MDR present?
The MDR has significantly tightened the labeling requirements for medical devices. Errors in labeling directly result in compliance findings:
- MDR Annex I, Chapter III sets out comprehensive minimum information requirements—many manufacturers are not yet in compliance.
- Multilingual IFUs (in all official EU languages) require professional translation management.
- The UDI marking on labels must be incorporated without any technical or content-related errors.
- The eIFU (electronic instructions for use) as an alternative to paper IFUs involves complex regulatory requirements.
Do your product labels and IFUs comply with the current MDR labeling requirements set forth in Annex I?
Our labeling and IFU services.
We develop comprehensive, MDR-compliant labeling concepts for your medical devices.
Labeling Strategy & Compliance Review
Review of existing labels and IFUs against MDR Annex I, GSPR No. 23, and relevant standards (ISO 15223-1, EN ISO 20417). Creation of new label designs, including mandatory information.
IFU Creation & Linguistic Optimization
Preparation of structured user manuals in German and English. Optimization of readability for both laypeople and professionals, including the incorporation of safety instructions and ISO symbols.
Multilingual Labeling & Translation Management
Coordination of IFU translation into all relevant official EU languages by expert native speakers. Ensuring terminological consistency through the use of translation memory.
eIFU Strategy in accordance with EU Regulation 207/2012
Consulting on the use of electronic instructions for use (eIFU) for professional users. Requirements analysis, submission of applications to regulatory authorities, and design of the eIFU portal.
Frequently Asked Questions About Labeling & IFU.
According to MDR, what must be included on the label of a medical device?
MDR Annex I, Section 23.2 requires, among other things: the manufacturer’s name and address, the UDI, the product description, the intended use (unless obvious), the lot/serial number, the expiration date, sterilization instructions, warnings, and the CE marking with the notified body’s identification number.
Does the IFU always have to be included in paper form?
Not necessarily. EU Regulation 207/2012 permits the use of eIFUs (electronic instructions for use) for products intended for professional users under certain conditions. For lay users and patients, a paper IFU is still required (unless an explicit request is approved).
What are the most common IFU findings in notified body audits?
Common errors: Missing or outdated risk warnings, incomplete contraindications, missing UDI information, use of symbols that does not comply with standards (ISO 15223), unclear storage conditions, and misleading instructions for use.
How many languages must an IFU be available in for the EU market?
Generally, in the language of the Member State where the product is marketed. For Europe-wide distribution, up to 24 official languages may be required, which can often be managed more efficiently through eIFU strategies.
Additional expertise in labeling.
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