Labelling Under the MDR
A label provides a wealth of information regarding your medical device that is communicated to the end user or patient. Therefore, it is of utmost importance that you have all the relevant information on the label as laid out in Annex I Section 23 of the MDR. Annex I 23.1 (h) states that; Where appropriate, ...
The European Commission’s Directorate-General for Health and Food Safety has published MDR and IVDR Language Requirements for Manufacturers.
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 ...
