When national language is required and when eIFU is allowed for medical devices in the EU

Medical device manufacturers, importers, and distributors operating within the European Union must meticulously adhere to stringent language requirements for Instructions for Use (IFU). These requirements are established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Ensuring compliance involves understanding the interplay between EU regulations and national competent authority stipulations.

#General Language Requirements for Instructions for Use

Both the MDR and IVDR specify that the information supplied with a medical device must be available in a language or languages determined by the Member State where the device is made available to the user or patient. This includes the IFU, labels, and all other information provided by the manufacturer. Article 10(11) MDR and Article 10(10) IVDR state that manufacturers must ensure the device is accompanied by information in an official Union language or languages as required by the Member State where the device is sold.

This means that manufacturers must identify the specific linguistic requirements of each Member State where their devices will be marketed. National competent authorities often publish lists of accepted languages, typically their official national language(s).

#Distributor and Importer Obligations Regarding Language

Distributors and importers have specific responsibilities under the MDR and IVDR to ensure language compliance. Their roles are distinct, yet both contribute to the availability of compliant devices on the market.

#Importer Responsibilities

Importers must verify that the device bears the CE marking and that a Declaration of Conformity has been drawn up. Critically, Article 13(3) MDR and Article 13(3) IVDR require importers to ensure that the device is labelled in accordance with the regulations and accompanied by the required information. This includes ensuring the IFU is provided in the language or languages required by the Member State where the device is intended to be placed.

Should an importer have reason to believe that a device is not compliant, they must not place it on the market. They must inform the manufacturer and, where appropriate, the manufacturer's authorised representative, and the competent authority of the Member State in which they are established. This obligation extends to language compliance.

#Distributor Responsibilities

Distributors, too, must act with due care regarding applicable requirements. Article 14(2) MDR and Article 14(2) IVDR state that before making a device available on the market, distributors must verify that the device is labelled in accordance with the regulations and accompanied by the required information. This again includes the IFU being in the language or languages required by the Member State where the device is to be sold.

If a distributor considers or has reason to believe that a device is not compliant with the MDR or IVDR, they must not make the device available on the market. They must inform the manufacturer and, where appropriate, the manufacturer's authorised representative, the importer, and the competent authority of the Member State in which they are established. Distributors must cooperate with competent authorities in any action taken to ensure compliance.

Both importers and distributors must therefore be vigilant regarding national language requirements. They must verify that the manufacturer has provided the correct language versions of the IFU before making devices available on the market. For more information on overall labelling requirements, consult our article, "Mandatory Label Elements and Common Errors in Medical Device Labelling under MDR".

#Electronic Instructions for Use (eIFU)

In certain circumstances, manufacturers may provide IFUs in electronic form (eIFU) instead of in paper form. The conditions for using eIFU are primarily detailed in Commission Implementing Regulation (EU) 2021/2226, which repeals and replaces Regulation (EU) No 207/2012 for medical devices. This implementing regulation outlines the rules for eIFU under the MDR and IVDR.

#Conditions for Permitting eIFU

The general principle is that IFUs must be provided in paper form. However, Article 3 of Commission Implementing Regulation (EU) 2021/2226 permits eIFU for:

• Devices intended exclusively for professional users: This applies to devices that are not intended for use by lay persons.
• Implantable devices and active implantable devices: These device types may also have eIFU.

For devices intended for professional use, the eIFU must be accessible through the manufacturer's website. The manufacturer must also provide information on the device or its packaging regarding how to access the eIFU. Furthermore, a paper copy of the IFU must be provided free of charge upon request by the user, within a maximum of 7 calendar days.

#Devices Where eIFU is Not Allowed

Article 4 of Commission Implementing Regulation (EU) 2021/2226 specifies that eIFU is generally not permitted for devices intended for use by lay persons, unless the device is an implantable device or an active implantable device.

Manufacturers must also have a system in place to indicate when an eIFU has been revised and ensure that the previous versions are available. They must also indicate on the device or its packaging how to access the eIFU.

#The Role of EUDAMED

EUDAMED, the European Databank on Medical Devices, is a crucial component of the EU's regulatory framework. While EUDAMED does not directly host IFUs, it serves as a central repository for various device-related data, facilitating transparency and surveillance. The Device Module, for instance, requires extensive information about devices, which indirectly relates to the IFU content.

Currently, some EUDAMED modules are voluntary, while others are mandatory. The full functionality and mandatory use of all modules are still subject to a future Commission notice. It is imperative that all economic operators, including distributors and importers, confirm the current status and scope of EUDAMED requirements with their national competent authority, as this can impact data submission and transparency obligations. The EUDAMED AI platform can assist with managing and tracking various data points relevant to regulatory compliance, including those related to device registration and post-market surveillance. More details are available at eudamedai.com/#funkcije.

#Common Mistakes in Practice

• Failure to verify national language requirements: Assuming English is sufficient across the EU. Each Member State specifies its own required language(s) for the IFU.
• Incomplete translation: Translating only parts of the IFU, or using poor quality machine translations without professional review.
• Incorrectly applying eIFU rules: Providing eIFU for devices intended for lay persons when not permitted by implementing regulations (e.g., non-implantable Class IIa devices for home use).
• Lack of system for providing paper IFU on demand: Failing to have a clear, efficient process to supply a paper copy within the stipulated timeframe when eIFU is used.
• Outdated IFU versions: Not ensuring that the IFU available (either paper or electronic) is the latest approved version.
• Inadequate accessibility for eIFU: Websites being down, difficult to navigate, or not clearly indicated on the device labelling.
• Confusing EU REP and EC REP symbols: While not directly related to language, ensuring correct labelling including the authorised representative symbol is fundamental. Consult "EU REP vs EC REP Symbol: Why the Old Symbol Signals Outdated Documentation" for further details.

Manufacturers, importers, and distributors must proactively engage with national competent authorities and regulatory guidance documents to ensure full compliance with IFU language requirements. These obligations are central to device safety and efficacy.

This material is for information only and is not legal advice. For binding interpretation consult your national competent authority.