Guidance

DEHP phthalates in medical devices

Information for manufacturers and users of medical devices containing plastic with DEHP phthalates.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 10 September 2015
• Last updated: 1 July 2023
  Show all updates

  1. 1 July 2023

     This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.

  2. 17 May 2023

     Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.

  3. 26 January 2021

     Updated to reflect changes in regulations following the Brexit transition.

  4. 10 September 2015

     First published.

Documents

DEHP phthalates in medical devices

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Details

This guidance covers:

• what a phthalate is
• medical devices containing plastic with DEHP
• safety concerns
• legal requirements