Regulating Medical Devices from 1st January 2021
The Medicines and Healthcare Products Regulatory Agency (MHRA), has today issued guidance on the regulation of medical devices (medical devices and in-Vitro diagnostic medical devices) from 1st January 2021.
CE marking will continue to be used and recognised in Great Britain until 30th June 2023. A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1st January 2021. From 1st July 2023, to place a device on the Great Britain market, you will need to meet the requirements for placing a UKCA mark on your device. This requirement will not apply to Northern Ireland traders. Headline details, along with slightly different arrangements for Northern Ireland to accommodate the terms of the Northern Ireland Protocol, can be found in this factsheet. ABHI is currently working through the guidance with the MHRA and we will be holding a virtual briefing for members in the coming weeks.
This guidance is a practical and pragmatic response to the end of the EU exit Transition Period. UK government had initially issued guidance saying that CE marking would be recognised for a time limited period, although this was later withdrawn as negotiations with the EU intensified. ABHI has consistently advocated alignment with EU regulatory arrangements in the short to medium term, and a two and a half year period of continuity is much preferable to the emergency provisions that would have otherwise needed to be put in place. Our efforts will now focus on ensuring that the UKCA Mark process does not add unnecessary duplication and costs, and is consistent with the UK’s ambition to play a significant role in global medical device regulation.
To provide an update on the guidance, the DHSC will hold a webinar on Thursday 3rd September, 9:30am. The link to register is available here.
Peter Ellingworth, Chief Executive