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Regulation (EU) 2017/746 of the European Parliament and of the CouncilShow full title

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)

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Changes over time for: Division 3.2.

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Version Superseded: 31/12/2020

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Point in time view as at 31/01/2020.

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There are currently no known outstanding effects by UK legislation for Regulation (EU) 2017/746 of the European Parliament and of the Council, Division 3.2.. Help about Changes to Legislation

3.2.The manufacturer shall give authorisation to the notified body to carry out all the necessary audits, including on-site audits, and supply it with all relevant information, in particular:U.K.
  • the documentation on its quality management system,

  • the documentation on any findings and conclusions resulting from the application of the post-market surveillance plan, including the PMPF plan, for a representative sample of devices, and of the provisions on vigilance set out in Articles 82 to 87,

  • the data stipulated in the part of the quality management system relating to design, such as the results of analyses, calculations, tests and the solutions adopted regarding the risk-management as referred to in Section 4 of Annex I,

  • the data stipulated in the part of the quality management system relating to manufacture, such as quality control reports and test data, calibration data, and records on the qualifications of the personnel concerned.

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