April 27, 2023
The UK MHRA announced new dates to accept CE Marking & for their Medical Device Regulation. Find out the compliance requirements here.
March 28, 2023
The UK MHRA announced today that legacy CE Certificates granted further extension in Europe, will be recognized in Great Britain. Click here for more details.
March 7, 2023
The UK government released details regarding international recognition with other regulatory agencies (e.g., US FDA) ...
February 20, 2023
The MHRA released a statement today regarding the EU Commission’s intent to extend the MDR transition period. Find out how the MDR delay impacts the UK.
January 31, 2023
Today the MHRA announced increased application fees, starting April 2023. Click here to find out the new medical device registration, amendment, and clinical investigation fees.
January 4, 2023
Find out what regulatory news you may have missed from the MHRA in 2022, and to see the upcoming 2023 deadlines for medical devices & IVDs in the UK and Great Britain.
December 6, 2022
The MHRA updated its Medical Device Registration guidance to confirm that companies may not use their logo or make certain claims related to their MHRA registration.
October 25, 2022
It's official. The MHRA announced a one year delay for UKCA Marking. And confirmed a 3-5 year transition period, to continue to accept CE Marked devices. Read more here.
October 11, 2022
The MHRA has updated how incident reports can be submitted in the UK. Find out when the old system expires and how to register for the new UK vigilance portal.