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  2. Regulation (EU) 2017/745 - Wikipedia

    en.wikipedia.org/wiki/Regulation_(EU)_2017/745

    Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021. The regulation was published on 5 April 2017 ...

  3. Medical device - Wikipedia

    en.wikipedia.org/wiki/Medical_device

    This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...

  4. Medical Devices Directive - Wikipedia

    en.wikipedia.org/wiki/Medical_Devices_Directive

    The Medical Device Directive — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices —is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market ...

  5. EU to start China probe on medical device procurement ... - AOL

    www.aol.com/news/eu-start-china-probe-medical...

    April 15, 2024 at 5:14 AM. (Reuters) -The European Union is set to launch an investigation into China's procurement of medical devices to address concerns that Beijing's policies are unfairly ...

  6. Medical Device Regulation Act - Wikipedia

    en.wikipedia.org/wiki/Medical_Device_Regulation_Act

    Classification Panels for Medical Devices. Classification panels are to determine which devices intended for human use should be subject to the requirements of class I - general controls, class II - performance standards, or class III - premarket approval. Classification panels are to provide notice to the manufacturers and importers of medical ...

  7. Medical device reporting - Wikipedia

    en.wikipedia.org/wiki/Medical_device_reporting

    Medical device reporting ( MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled. Consumers and health professionals report ...

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