Regulatory Affairs Analyst Interview Questions and Answers

EU-MDR stands for European Union Medical Device Regulation.

• EU-MDR is a set of regulations that govern the safety and performance of medical devices in the European Union.

• It replaces the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD).

• EU-MDR aims to enhance patient safety, improve transparency, and strengthen the regulatory framework for medical devices.

• It introduces new requirements for clinical evidence, post-market surveillanc...read more