January 25, 2024 UK and EU End Users Are Not Importers Generally speaking, end users are not considered to be importers. This is the same for the UK and the MDD/MDR alike. For example, the European Commission’s Directorate-General (DG) for Health and Food Safety advised me of that interpretation regarding the MDR, specifically […]
<h1 class="entry-title">Category: UK MDR</h1>
Are DoC Updates Required for Software Version Changes?
January 22, 2024 Are DoC Updates Required for Software Version Changes? In general, yes. I explain: Remember that the MDR requires the manufacturer to “continuously update the EU declaration of conformity”. For example, if the Technical Documentation (TD) is different for version 3.0 compared to 3.1 to 3.1.1 to 3.2, then the […]