How do medical device manufacturers and distributors apply for UKCA certification and MHRA registration? Following Brexit, the UKCA mark will come into force in Great Britain in January 2021. Some classified medical devices may be required to hold UKCA certification, which can be obtained from a UK licensing body.
The transition period for UKCA will last until 30 June 2023 to allow for changes from existing CE certificates to UKCA certificates. However, the consultation on new UK legislation has ended, so new UK legislation should be published later this year.
From 1 January 2021, medical devices, whether they hold UKCA certification or CE certification, will be registered with the MHRA before being placed on the UK market. The grace period for device registration based on the risk level of the device has now ended. As a result, all devices are need to be registered with the MHRA(Medicines and Healthcare products Regulatory Agency) before being placed on the UK market.
For Northern Ireland, the EU MDR and IVDR will be implemented from 26 May 2021 and 26 May 2022 respectively. Even after 1 July 2023, medical devices marketed in Northern Ireland will still need to hold the CE mark and manufacturers will need to meet EU regulations.
Lingfu Technology assists medical device manufacturers in exporting to the UK: UK authorized representative, UK MHRA registration, UKCA certification, UKCA technical document preparation.
