MDR Language Requirements in France
The EU-Medical Device Regulation (EU) 2017/745 has been in effect since 26 May 2021, and it applies to all medical devices that are sold or distributed in all EU-Member States. This implementation has affected all medical device industries.
One of the key aspects of the regulation is the language requirements that apply to medical devices. In this article, we will explore the language requirements for medical devices in France, which is one of the EU's largest markets, and how they relate to the implementation of the new regulation.
The National Agency for the Safety of Medicines and Medical Devices (ANSM) is the competent authority in France, which ensures the safety of medical devices and promotes access to therapeutic innovation, on behalf of the French government. The implementation of the MDR is set out in the Ordninace 2022-582 from April 2022.
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The labeling and IFUs for medical devices must be provided in French, according to the French Public Health Code. This requirement applies to all medical devices, regardless of whether they are manufactured in France or imported from another country. If you are in doubt, you can also ask your notified body.
“The labelling of a medical device given to the end user or patient, the accompanying instructions and any other information relating to its operation or use shall include a version written in French.” - (FPHC Art. R5211-20)
The EU declaration of conformity is an official document that declares a medical device's compliance with EU product requirements. This document must be signed by the manufacturer or their authorized representative (AR) and submitted to the competent authority of the target market. In France, this authority is the ANSM.
According to Article 19.1 of the EU-MDR, the EU declaration of conformity must be translated into an official language of the European Union Member State(s) where the device is made available. In France, this means that the declaration of conformity must be provided in in the national language: French.
The implant card (IC) is a document that must be provided to the patient by the manufacturer. The IC contains information that identifies the implanted device, such as the device name, serial number, and lot number. It also includes the manufacturer's name, address, and website.
The French Public Health Code does not mention any specific language requirement for the implant card, however, following the MDR regulation the IC should be submitted in a language that is easily understood by the intended user or patient. In this case it will make sense to provide it in French. The purpose of the IC is to enable the patient to access detailed information about the implanted device and to allow healthcare professionals to take appropriate measures in emergency situations.
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 the MDR the FSN should be provided in French, since it is the national language. This ensures that the communication is clear and understandable to French users.
Manufacturers, distributors, and importers are all responsible for ensuring that their medical devices comply with the language requirements in France. They must have a quality management system in place that includes procedures to ensure that all information is accurate and up-to-date (Article 16.3 of the MDR).
Manufacturers are also responsible for ensuring that their translations are of high quality. They may use professional translation services. Regardless of the approach, the translations must be accurate and in compliance with the language requirements set out by the ANSM and the EU-MDR.
To be on the safe side manufacturers and distributors should use preferably a certified language provider. Possible quality standards a professional translation company can have, are ISO 9001, ISO 17100 and, very important for medical devices, ISO 13485. This is one way to ensure “accurate translation” according to the EU-MDR.
A special translation process and medical translators should be involved in the procedure. Especially if it is a risk class III medical device, these measures must be taken.
In conclusion, the language requirements for medical devices in France are clear and must be strictly adhered to. The ANSM has set out specific requirements for labeling, IFUs, the EU declaration of conformity, the implant card, and the field safety notice. Manufacturers, distributors, and importers must all have a quality management system in place to ensure compliance with these requirements.
It is important to note that failure to comply with these language requirements can result in serious consequences, including the withdrawal of the medical device from the French market, fines, and legal action.
Therefore, it is essential for all stakeholders to understand and comply with the language requirements for medical devices in France, as they play a critical role in ensuring patient safety and the overall quality of medical devices in the market.
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Alejandra Keller is a German and Spanish native speaker with a high level of proficiency in English. She holds a translation degree from the University of Heidelberg and has lived and studied in Germany, the United States, Ireland, Spain and Peru. With a strong passion for international communication, she is currently working as Project Manager at AbroadLink.