Medical devices: what are the language requirements for regulatory documentation?

2021-10-20

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A medical device (MD) is an instrument, software or other material used for clinical purposes¹, including the prevention, monitoring, diagnosis or treatment of an illness or injury. These products are distinguished from medicines for not causing any pharmacological, metabolic or immunological action.

To be marketed in European countries, MDs must have CE marking.

CE marking: a passport to market medical devices in the EU

“CE” is an abbreviation for the French designation Conformité Européene, which means European conformity. CE marking is a legal requirement for the free movement and marketing of an MD in the European market, and is a key indicator that the product is in compliance with EU legislation.

The certification process is long and demanding, and includes several steps:

Figure 1: General steps of activities in compliance with European regulations for the affixing of CE marking

Figure 1 - General steps of activities in compliance with European regulations for the affixing of CE marking (adapted from Freitas, A. S. B. - Medical Devices: Regulatory Framework and Technical Documentation ²).

Language requirements to obtain CE marking for medical devices

At the European Union (EU) website, one can find the MD Regulation containing a complete list of requirements for obtaining CE marking, including a list of several linguistic requirements:

  1. The manufacturer must provide a label and instructions for use for the MD.
    This information must appear on the device itself, its packaging and website (if applicable), and be written in the official language of the country in which the product is marketed (Article 10). Chapter III of Annex I has a list of information to be included in the label and in the instructions for use.
    Both must be indelible, easily legible and clearly comprehensible to the device’s intended user. Learn here how to do this effectively.
  2. The manufacturer must provide and continuously update the EU declaration of conformity.
    This declaration must contain the information listed in Annex IV to the MD Regulation, including versions in the official language of the Member States in which the device is marketed (Article 19).
  3. The manufacturer must compile a complete file of technical information prior to the placement of the MD on the market.
    All products subject to one of the three MD directives - Directive 90/385/EEC relating to active implantable MDs; 93/42/EEC relating to MDs; and 98/79/EEC elating to in vitro diagnostic MDs - require the existence of a Technical File/Design File.

This technical documentation is an exhaustive compilation of all relevant information on the device, including how it works, how it is made and how it complies with applicable legislation. The content of the Technical File/Design File is regulated by the MD directives, and can be decisive in the process of obtaining CE marking, above all if this document is poorly structured, if its information is inconsistent or if it has omissions.

Challenges in translating regulatory documents for medical devices

Depending on distribution and marketing goals, some products may require regulatory information to be translated into 24 languages. Furthermore, depending on the classification, each label and instructions for use may require more than 20 information pieces ³.

As previously stated, each country requires information on the medical device to be written in the language of local users. Therefore, structuring the necessary documents, identifying target languages and including the translation (https://www.l10nglobal.com/en/news/medical-translation-what-is-it-and-why-is-it-important) of all regulatory materials in general development strategies are key points in the success of affixing CE marking and, consequently, for placing the MD on the market in a more expeditious manner.

References:
¹ Regulation (EU) 2017/745 on medical devices, available at https://eur-lex.europa.eu/eli/reg/2017/745/2017-05-05. Accessed in September 2021.

² Freitas, A. S. B. - Dispositivos Médicos: Enquadramento Regulamentar e Documentação Técnica (Medical Devices: Regulatory Framework and Technical Documentation). Portuguese Pharmacists' Association, Department of Regulatory Affairs. July 2014

³ Argos Multilingual. Regulatory language requirements for medical devices in the European Union. Available at: https://www.argosmultilingual.com/wp-content/uploads/2018/10/Regulatory-Language-Requirements-for-Medical-Devices-in-the-EU.pdf. Accessed in September 2021.


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