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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 placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).

  3. File:The Medical Devices Regulations 2002 (UKSI 2002-618).pdf

    en.wikipedia.org/wiki/File:The_Medical_Devices...

    English: These Regulations contain the legislative measures necessary for the implementation of three European Community Directives- Council Directive 90-385-EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93-42-EEC concerning medical devices, as amended; and Directive 98-79-EC of the European Parliament ...

  4. Medical Device User Fee and Modernization Act - Wikipedia

    en.wikipedia.org/wiki/Medical_Device_User_Fee...

    Added two types of annual fees: establishment registration fee and product fee 2012: MDUFA III: Safety and Innovation Act of 2012: Expanded the definition of establishments subject to a registration fee, thus increasing the applicable device establishments paying the fee. 2017: MDUFA IV: FDA Reauthorization Act of 2017

  5. Regulation (EU) 2017/746 - Wikipedia

    en.wikipedia.org/wiki/Regulation_(EU)_2017/746

    Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.

  6. 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 the ...

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  9. Category:Regulation of medical devices - Wikipedia

    en.wikipedia.org/wiki/Category:Regulation_of...

    Medical Devices regulations cover all the topics related to the laws, standards or submissions process, with which compliance is required by manifold national and international bodies to commercialize a medical device