Timelines for acceptance of CE marked medical devices in Great Britain (GB)
Published 16 February 2026
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This publication is available at https://www.gov.uk/government/publications/timelines-for-acceptance-of-ce-marked-medical-devices-in-great-britain-gb/timelines-for-acceptance-of-ce-marked-medical-devices-in-great-britain-gb
A consultation on proposals for indefinite recognition of CE marked medical devices in Great Britain (GB) is open from 16 February to 10 April 2026.
Whilst responses are sought and considered, the above transition arrangements remain in place.
The government put in place legislation that amends The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) to extend the acceptance of CE marked medical devices on the GB market. This supports the ongoing safe supply of medical devices to GB and eases the transition to the future regulatory framework for medical devices.
The legislation provides that CE marked medical devices may be placed on the GB market to the following timelines:
- general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the GB market up until the sooner of expiry of certificate or 30 June 2028
- in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the GB market up until the sooner of expiry of certificate or 30 June 2030, and
- general medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the GB market up until the 30 June 2030.
This enables certain CE marked medical devices to continue to be placed on the GB market for longer.
The legislation provides for self-declared CE marked Class I medical devices to be placed on the GB market beyond 30 June 2023 if they are:
- self-declared against EU MDR requirements (until 30 June 2030), or
- self-declared against EU MDD requirements before 26 May 2021 where Notified Body involvement in their assessment is not required under EU MDD but is required under EU MDR (until 30 June 2028). This includes upclassified devices and reusable surgical instruments.
It also provides for a Class I medical device which has a sterile or measuring function with a valid EU MDD certificate to be placed on the GB market until 30 June 2028.
Class I medical devices and general IVDs under the Directives, for which the conformity assessment under the EU MDD or EU IVDD did not require a notified body, can only be placed on the GB market if the involvement of a notified body would be required under the EU MDR or IVDR (that is, if it is an upclassified device or a reusable surgical instrument Class I device). Custom-made devices that are compliant with the EU MDD or EU AIMDD can no longer be placed on the GB market.
If placing medical devices on the GB market under these transitional measures, manufacturers will not be able to rely on expired certificates (unless such certificates have been otherwise deemed valid by the EU).
An infographic of the timelines for placement of CE marked medical devices on the Great Britain market under the Medical Devices (Amendment) (Great Britain) Regulations 2023 is available for download.