The UK has decided to continue recognising the CE mark, however, both sides need to agree on a common way to describe ...
Under the EU MDR, manufacturers must prepare and submit a comprehensive Technical Documentation File for devices that require CE marking. The Clinical Evaluation Report (CER) is a crucial component of ...
Since 1993, the conformité européenne (CE) mark has been used to show a wide variety of products meet EU legal requirements and have been tested. For products sold in England, Wales and Scotland ...