The Medical Device Regulation (MDR) is a European Union law that came into effect in May 2021, replacing the previous Medical Device Directive (MDD). MDR establishes strict requirements for the safety, performance, and approval of medical devices, including certain types of software used in healthcare. It aims to ensure that all medical devices marketed in the EU meet high standards for quality and patient safety. MDR also introduces more rigorous post-market surveillance, traceability, and transparency measures, impacting manufacturers, importers, and healthcare providers. Compliance with MDR is mandatory for companies wishing to sell medical devices in the European Union.