RAC Devices EU MDR Test Q&A Latest Update

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RAC Devices EU MDR | Q&A Latest 2025/2026 | 100% PASS Notified Body - Answer -organization accredited by and EU Member State and notified to the European Commission to assess whether a product meets preordained standards via inspection and examination of the product, its design, and manufacture. Memorandum of Understanding (MOU) - Answer -Agreement between regulatory authorities allowing mutual recognition of inspections National Competent Authority Report (NCAR) - Answer -Used to exchange information among Competent Authorities on serious adverse events involving medical devices European Association of Authorised Representatives (EAAR) - Answer Represents organizations that provide European Authorized Representative services to non-European manufacturers of medical devices and in-vitro diagnostic medical devices Notified Body Operations Group (NBOG) - Answer -Organizations that works to improve the performance of Notified Bodies and the authorities responsible for them European Association of Notified Bodies for Medical Devices (Team-NB) - Answer -organization comprised of 26 members represent 14 different countries, that promote high standards and protects the interests of Notified Bodies