April 27, 2020
Repackaging of a medical device or translated its labelling
The purpose of this article is to address the interpretation of the provisions in Article 16 of EU Regulation 2017/745. Recently, misinterpretations of the regulations contained in that Article have been voiced at medical device conferences. Our analysis and its outcome are consistent with the interpretation advocated by 27 notified bodies in the area of medical devices that take part in regular meetings of the Notified Body Group. It is not by chance the fact that those meetings are also attended by representatives of the European Commission.