MHRA: Independent Regulation of CE Marking of Medical Devices
On 1 August 2023, the UK government published a statement on the indefinite extension of CE marking recognition beyond 2024. MHRA clarifies: This extension does not apply to medical devices and in vitro diagnostic medical devices.
Short recap:
At the end of last year, the MHRA announced that the implementation of the forthcoming UK medical device regulation and UKCA certification would be postponed by 12 months to July 2024. The statement said that manufacturers could continue to place CE marked medical devices on the market, in order to guarantee the continuous supply of medicines to UK patients (we reported). From July 2024, the transitional arrangement for the use of both CE and UKCA marked devices will then apply.
UKCA is the equivalent of the European CE marking, which is used to certify medical devices, among other things.
In the statement of 1 August 2023, the MHRA explicitly states that the UK Government's decision to support the indefinite recognition of CE marking for the time being does not apply to medical devices and in vitro diagnostic medical devices. For such products, the announced transition period from CE to UKCA marking shall be applicable as of 1 July 2024. By 2030 at the latest, CE marked medical devices are no longer to be approved. It states:
- 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 Great Britain 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 Great Britain 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 Great Britain market up until the 30 June 2030.
The current status and detailed information on the implementation of the stand-alone UK regulation can be found here.
Source:
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