Medical Device Regulation (MDR)

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The Medical Device Regulation (MDR) is a regulation passed by the European Union (EU). It  governs the safety and performance of medical devices sold in the EU. It was designed to improve the safety of medical devices and ensure that they meet the latest technological and scientific standards. The MDR replaces the previous Medical Device Directive (MDD) and includes stricter regulations for medical devices. This includes more extensive clinical evaluations, stricter post-market surveillance requirements, and a new EU-wide database of medical devices.