The EU is made up from 27 countries, most of them having their own national language. Since there is no official language of the European Union, each member state has different requirements that would need to be respected when making a device available in a particular member state. The MDR and IVDR both contain legal provisions that allow Member States to determine language requirements for manufacturers at national level for information accompanying the device.
Due to the above, it can sometimes be quite challenging to determine what the language requirements in a particular member state are, where in some states, it would seem that more than one language is required. This can be made even more confusing as the language requirements can vary depending on the intended end user of the device, i.e., whether the device is intended to be used by a lay user, or by a professional.
In an attempt to help manufacturers understand these different language requirements, the EU Commission has published two tables, one for MDR and one for IVDR, that highlight the language requirements in each of the member states for different documents that accompany a medical device, such as;
- Label
- Instructions for Use (IFU)
- Declaration of Conformity (DoC)
- Field Safety Notice (FSN)
- Documents for Conformity Assessment
- Graphic user Interface (Apps)
Taking a look at the Label and IFU section, these are further split into two parts outlining the language requirements for medical devices if it is being used by a lay user, or professional user. With regard to the IVDR, the language requirements are split based on whether the device is intended to be used by a professional user or is a device for near patient testing.
We urge all manufacturers to consult this table prior to making their device available on a particular market. The tables can be accessed using the following links:
