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  2. Custom-made medical device - Wikipedia

    en.wikipedia.org/wiki/Custom-made_medical_device

    Jurisdiction Definition Legislation Australia A medical device that: (a) is made specifically in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and (b) is intended: (i) to be used only in relation to a particular individual; or (ii) to be used by the health professional to meet special needs arising in the course ...

  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. 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

  5. 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as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...

  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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  8. Regulation (EU) 2017/745 - Wikipedia

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

    Regulation; European Union regulation: Title: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)

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