EUDAMED modules：What is EUDAMED and what new requirements should ...

What is EUDAMED and what new requirements should ...

2022年1月25日—Theremainingthreemodules(ClinicalInvestigationsandPerformanceStudies,VigilanceandPost-MarketSurveillance,andMarketSurveillance) ...。其他文章還包含有：「EUDAMEDOverview」、「EUDAMEDdatabase」、「MedicalDevices」、「TheSixEUDAMEDModules(MDR)」、「MedicalDevices」、「Actorregistrationmodule」、「NotifiedBodiesandCertificatesmodule」、「FunctionalspecificationsfortheEuropeanDatabase...

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EUDAMED Overview

https://health.ec.europa.eu

... EUDAMED. EUDAMED is structured around 6 interconnected modules and a public website: Actors registration · UDI/Devices registration · Notified Bodies and ...

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EUDAMED database

https://ec.europa.eu

EUDAMED will be composed of six modules related to: actor registration, unique device identification (UDI) and device registration, notified bodies and ...

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Medical Devices

https://health.ec.europa.eu

The Actor registration is the first of the six EUDAMED modules. UDI/Devices registration. Regulation (EU) 2017/745 on medical devices and Regulation (EU) ...

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The Six EUDAMED Modules (MDR)

https://www.tracekey.com

The EUDAMED (MDR) is divided into six modules. They serve registration, data exchange, monitoring, and transparency.

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Medical Devices

https://health.ec.europa.eu

The EUDAMED UDI/Devices and NBs & Certificates modules are open. Economic Operators and Notified Bodies can start entering data in EUDAMED on ...

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Actor registration module

https://health.ec.europa.eu

The Actor registration is the first of the six EUDAMED modules.

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Notified Bodies and Certificates module

https://health.ec.europa.eu

Therefore, in EUDAMED, NBs can register certificates and Summaries of Safety and Clinical Performance (SSCP) only on voluntary basis if all of the parties ...

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