MDR Language Requirements

The Medical Device Regulation (MDR) 2017/745 was implemented not only to ensure users' access to performance data and to increase patient safety, but also to comply with the EU’s promotion of multilingualism and the goal of linguistic diversity as key values reconciled in the Treaty on the European Union. However, the regulations translate into expanded linguistic requirements for MedTech manufacturers and their business contents.

There are 24 official EU-languages, counting all 30 Member States of the EU-single market (EU and EEA). Each and every state needs to be taken into consideration if your medical device is to be sold in European countries, since the Regulations’ language requirements are bound to national legislation as the article 10 of Regulation 2017/745 states:

“Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient.”

1. Language requirements to be determined by national law

The language requirements are left up to 30 national legislatures, so manufactures need to adapt their product language to the country where they want to market it. Some Member States have several official languages others only one, while there are also different language requirements for layperson content and professional user content.

2. Labeling, Packaging and Instructions for Use

We can generally remember: All patient user information must be available in the country’s official language(s). This is mandatory to ensure patient safety. This rule changes if the device is only to be used by professionals. Annex II, article 2, of the EU Regulation 2017/745 states:

“— the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold.”

“— the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold; and.” 

Here is a short overview of the languages accepted by Member States regarding the medical device user orientation:

(*) indicates that there are exceptions

3. Declaration of Conformity

The requirements for the declaration of conformity are at first sight the same as for labelling, packaging and IFUs, but don’t let appearances deceive you. As already mentioned before, regulations and laws are always subject to interpretation. The declaration of conformity is an official document declaring the compliance of EU product requirements, signed by manufacturers/REPs and presented to the competent authority of the target market. Therefore, the language requirements differ to those applicable to user requirements. For instance, in contrast to labelling, English is widely accepted among many Member State authorities.

Article 19.1 of the EU MDR states: “The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.”

Don’t forget that “all information and documentation necessary to demonstrate the conformity of the device” is subject to the same requirement. (2017/745 Art. 11, d.)

4. Implant Card

The Implant Card (IC) must be provided by manufacturers to the patient.

As stated in article 18.1(a) of the EU Regulation, it needs to include:

“Information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer;”

The purposes of ICs are:

• to enable the patient to get access to detailed information related with the implanted device
• to enable patients to make own security checks
• to enable health care professionals to take right measures in emergency situations

Article 18.1 precises: “The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State.”

5. Field Safety Notice (FSN)

As manufacturer/REP you are responsible for the safety of all users. As soon as there is any safety risk related to your medical device you must send out an official communication detailing field corrective actions to follow by any user, that’s to say, a Field Safety Notice. This information needs to be “consistent in all Member States” and, due to its relevant content, Article 89.8. established

“The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken.”

6. What Role do Distributors and Importers Play to Fulfil Language Requirements?

Apart from manufacturers, distributors and importers also have to assume responsibility for quality assurance of the provided translations as reflected in Article 16.3 of the MDR:

“Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date […]”

7. Translation Procedures for your QM-System

The regulation leaves room for interpretations on how to prove that the translation quality is assured.

This is why manufactures, under the guidance of Notified Bodies’ auditors, may follow different strategies to prove their compliance with the law.

Approaches can vary from comprehensive procedures regarding translation, like complying with the standard ISO 17100 that requires an additional revision step after the texts have been translated by professional translators, requiring translation certificates to be signed by all linguists involved or creating a procedure for the qualification of critical suppliers, which, in case of translation providers, can be limited to the possession of certain certifications like the ISO 9001, ISO 17100 and ISO 13485.