ISO 18113 defines the requirements associated to labelling for In-Vitro Diagnostic Medical Devices. We have extensively discusse about labelling in several occasions within QualityMedDev website. For example in relation to

eIFU (electronic IFU) became more and more important in the last tears, due to the huge progress of digital health and digital medical devices. We have been extensively talking about

The introduction of the UDI system for the medical device business can be considered a revolution and now the MDR and IVDR will soon be fully implemented, it is necessary

In the last years, the reprocessing of medical devices started to play a critical role and additional requirements have been requested by competent authorities and regulators to ensure the safety

Although there are different ISO standards which define the requirements for labelling related to medical device, such us ISO 15223-1 and ISO 20417, FDA has also some specific requirements that