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Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for EMA and national …
Medical Device Regulation comes into application
- https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application
- Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021.. The Medical Device Regulation (MDR), which …
The European Union Medical Device Regulation – …
- https://eumdr.com/
- The Medical Device Coordination Group (MDCG) approved two further documents clarifying the timelines and requirements for using the EUDAMED database: Document …
Europe CE Marking Regulatory Process for Medical Devices
- https://www.emergobyul.com/resources/europe-ce-marking-regulatory-process-medical-devices
- Determine which EU Medical Device Directive applies to your device: …
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