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Compliance with Language Requirements

Any information provided by a manufacturer must be understood by the intended end-user so as to ensure that their device can function safely and perform as intended. This could be a problem when selling into the European Union (EU) / European Economic Area (EEA) which is currently made up of 28 EU countries, 3 in the EEA and Switzerland, with a total of 24 official EU languages.

With respect to medical devices, Article 4 of the Medical Device Directive (MDD) 93/42/EEC states that Member States “may require the information”, such as that on the label or Instructions for Use (IFU), “to be in their national language(s) or in another Community language”. The key word here is “may”, which would suggest that this may not be the case. It is the same in the case of in vitro diagnostic (IVD) medical devices, as seen in Article 4 of the IVD Directive (IVDD) 98/79/EC.

From our experience with manufacturers selling across EU this requirement is enforced with each Member State’s National Competent Authority expecting that the information provided by the manufacturer must be in their national language, if the device is made available in that country. With requirements for the sale of devices on the EU market becoming more stringent, manufacturers must ensure that the information provided meets this obligation.

EU Regulations 2017/745 and 2017/746, on medical devices and IVDs respectively, are now clear on this requirement, as is highlighted in Article 10 of both these Regulations:

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. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient. [Article 10(11) Regulation (EU) 2017/745]

Manufacturers shall ensure that the device is accompanied by the information set out in Section 20 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. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient. [Article 10(10) Regulation (EU) 2017/746]

Failure to meet these requirements will leave the manufacturer exposed to potential liability issues in the event of an incident related to the use of the device. Therefore, it is critical that the manufacturer provides the relevant translations of such information for all the countries in which their devices are used.

Although a list of official languages of each EU Member State is available, there is some level of uncertainty with regards to which languages a National Competent Authority will accept within their territory, a decision which may be affected by socio-political factors and which may change over time. Over the years, Advena has put together helpful resources which will ensure you are compliant with these requirements.

Advena are able to provide a cost effective translation service via a UK partner who specialises in translations for the medical sector and use linguistic expertise to ensure that the translation provided is of a standard fully acceptable to the appropriate regulatory authorities.

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