Following the government’s decision to extend the CE mark recognition for a wide range of products, the UK announced that for medical devices, the deadlines will not change.
CE marked medical devices on the Great Britain market
As communicated on 1 August 2023, the indefinite recognition of CE marking does not apply to medical devices and in vitro diagnostic medical devices. Consequently, the transitional periods stays the same as announced in July 2023. The amended Medical Device Regulations (UK MDR) extend the recognition of CE marked medical devices on the Great Britain market. The deadlines for CE marked medical devices are:
- Legacy medical devices: until certificate expiration or 30 June 2028
- Legacy IVD medical devices: until certificate expiration or 30 June 2030
- Medical devices, including custom-made, compliant with the EU Medical Devices Regulations (MDR or IVDR): until 30 June 2030
To know more about the latest changes on CE marking recognition for other products, check Indefinite CE Mark recognition in Great Britain, while CE recognition period extended: UK law officially published presents an in-depth explanation of the extension in Great Britain.
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