Medical devices – extended acceptance of CE marked medical devices on the Great Britain market

Subject to Parliamentary approval this will mean that CE marked medical devices will be accepted on the Great Britain market beyond the current deadline of 30 June 2023. This will support the ongoing, safe supply of medical devices to Great Britain and is designed to ease the transition to a future strengthened regulatory framework for medical devices. The government will ensure that there is a proportionate, phased approach to the implementation of the future regulatory framework, which supports system readiness and minimises the risk of supply disruption for UK patients.

Subject to Parliamentary approval this will mean that CE marked medical devices will be accepted on the Great Britain market beyond the current deadline of 30 June 2023. This will support the ongoing, safe supply of medical devices to Great Britain and is designed to ease the transition to a future strengthened regulatory framework for medical devices. The government will ensure that there is a proportionate, phased approach to the implementation of the future regulatory framework, which supports system readiness and minimises the risk of supply disruption for UK patients.
May 3, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) intends to introduce a statutory instrument before June 30, 2023, which will accept that CE marked medical devices be placed on the Great Britain market according to the following:

  • General MDs compliant with the EU MDD or EU AIMDD with a valid declaration and CE marking can be placed on the Great Britain market up until June 30, 2028 or the certificate expiry date, whichever comes first;
  • IVDs compliant with the EU IVDD can be placed on the Great Britain market up until certificate expiry date or June 30, 2030, whichever comes first; and
  • General MDs, including custom-made devices, compliant with EU MDR and IVDs compliant with the EU IVDR can be placed on the Great Britain market up until June 30, 2030.

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You can contact us at: medtech@asphalion.com

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