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Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- Jan 25, 2023
Medical Device Regulation comes into application
- https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application
- Medical Device Regulation comes into application. Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May …
First guidance on new rules for certain medical devices
- https://www.ema.europa.eu/en/news/first-guidance-new-rules-certain-medical-devices
- The new regulations introduce new roles and responsibilities for EMA and national competent authorities (NCAs) in relation to certain types of medical …
Questions & Answers for applicants, marketing …
- https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf
- For medical devices incorporating a medicinal substance with action ancillary to the device, Regulation (EU) 2017/745 Article 1 (8), the notified body shall seek a scientific opinion …
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