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 — See all updates

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
Published 10 September 2015
Last updated 1 July 2023 + show all updates

  1. 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. 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. Updated to reflect changes in regulations following the Brexit transition.

  4. First published.

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