MDR Language Requirements in Spain

As part of the EU-Medical Device Regulation (MDR) implementation, all medical device manufacturers must comply with language requirements in the EU. The European Union has 24 official languages and Spanish is one of them. Spain, as one of the largest EU markets, has specific language requirements for medical devices.

In this article, we will explore the language requirements for medical devices in Spain, including labeling and instructions for use (IFUs), the EU declaration of conformity, the implant card, and the field safety notice. We will also discuss technical documentation and language requirements for medical devices in Spain.

The Spanish Agency for Medicines and Medical Devices (AEMPS) is a governmental agency belonging to the Ministry of Health, Social Services and Equality. It is the competent authority for medical devices in Spain and is responsible for ensuring the quality, safety, efficacy and accurate information of medicines and health products from its research to use.

Language Requirements for Labeling and Instructions for Use (IFUs)

According to the Spanish Agency of Medicines and Medical Devices (AEMPS), all medical device labeling and IFUs must be provided in Spanish. The requirement applies to all medical devices, regardless of where they are manufactured. Additionally, manufacturers can provide labeling and IFUs in other languages, but at least in Spanish  (Art. 30 (5) Royal Decree 192/2023).

Manufacturers should always consult language requirements with their Notified Body and the local competent authority to determine their real translation needs and avoid unnecessary costs.

The AEMPS in compliance with the EU-MDR, requires that all translations are of high quality, and that the content is clear and easily understandable for the intended audience.

Language Requirements for the EU Declaration of Conformity

In Spain, the EU declaration of conformity must be translated into Spanish, as well as any other official languages of the EU- Member States where the device is made available. The local language is determined by the member state. The manufacturer or their authorized representative must sign the document, which must be submitted to the competent authority, in Spain, the AEMPS.

Language Requirements for the Implant Card

The implant card must contain information about the implanted device, including the name, serial number, and lot number of the device, as well as the manufacturer's name, address, and website. According to Article 36 (1) of Royal Decree 192/2023, the information on the implant card must be provided in Spanish. As part of the MDR-language requirements the manufacturer is obliged to make sure that the patient fully understands the provided information, therefore, it is to be submitted at least in the national language.

Language Requirements for the Field Safety Notice

The field safety notice (FSN) is a communication that manufacturers must send out in the event of a safety risk related to their medical device. The FSN provides details about the corrective actions that users should take. According to Article 35 (6) of Royal Decree 192/2023, the FSN must be provided only in Spanish. If the FSN is to be send out to a number of countries, then of course, the member state determines the required language.

Technical Documentation and Language Requirements

Medical device manufacturers must also ensure that their technical documentation is in compliance with the EU-MDR and the requirements from their notified Bodies. According to Article 52 (12) of the EU-MDR, the technical documentation must be supplied to the Notified Body in an EU-language. This means that manufacturers may need to provide translations of their technical documentation into the languages accepted by their notified body which will present this to the competent authority. However, in many cases English is accepted. The AEMPS requires at least Spanish for all technical documentation, but there may be exceptions for the the clinical investigation documentation, of which some may be admitted in English.

[...] provided that the IRB has no objection, the clinical investigation plan and the investigator's manual could be accepted in English. However, the AEMPS will always retain the authority to request their translation, as well as that of any other document in the dossier. 

Recommendations for Medical Device Manufacturers

To ensure compliance with the language requirements and regulations for medical devices in Spain and throughout Europe, medical device manufacturers should consider working with a certified language provider with expertise in medical device translation. ISO 9001, ISO 17100, and ISO 13485 certified language providers are recommended for the translation of medical device documentation. These certifications ensure that the language provider follows strict quality management processes and adheres to industry standards for medical device translation.

It is also important for medical device manufacturers to involve medical translators with technical knowledge, experience and linguistic talent. Translators with a deep understanding of medical terminology and the regulatory landscape can ensure that translations are accurate, clear, and easily understood by the intended audience. This is especially important for medical devices in higher risk classes, where the accuracy of the technical documentation is crucial for ensuring patient safety.

In addition to working with certified language providers and qualified translators, medical device manufacturers can take other steps to ensure the accuracy and quality of their translations. For example, it may be helpful to provide glossaries and reference materials to translators to ensure consistent use of terminology. Providing context and background information about the medical device can also help translators understand the intended audience and ensure that translations are appropriate for the target market.

Conclusion

Compliance with the language requirements and regulations for medical devices is essential for ensuring patient safety and market access in Spain. Medical device manufacturers must comply with the language requirements for labeling, instructions for use, the EU declaration of conformity, the implant card, and the field safety notice set out by the AEMPS and the EU-MDR.

They must also ensure that their technical documentation is in compliance with the EU-MDR and translated into the languages required by the competent authorities of the Member States where the device is made available.

To ensure compliance, manufacturers should work with certified language providers and involve qualified medical translators with expertise in the field of medical devices. This can help manufacturers navigate the Spanish market and expand their reach throughout Europe, while also ensuring the safety and efficacy of their medical devices.