August 29, 2023

Three New UK Approved Bodies Available for UKCA Marking

The MHRA has designated three additional UK Approved Bodies. Click for the link to see the full list of available UK Approved Bodies for UKCA Marking.
August 1, 2023

UK MHRA Clarifies CE Marking Timeframes for Medical Devices & IVDs

The MHRA clarifies that the UK Department of Business and Trade's announcement regarding "indefinite CE mark recognition" does not apply to medical devices.
July 27, 2023

UK MHRA Post-Market Surveillance: Draft Legislation Released

The draft UK Post-market Surveillance (PMS) Requirements have been published. What are the proposed new PMS requirements & when will they go into effect?
July 17, 2023

New MHRA Guidance: Marketing IVDs in Great Britain

Today the UK MHRA released a new guidance document on how to market IVD devices in Great Britain. Click here for the full update.
July 4, 2023

UK MHRA: Update on Plan to Recognize Approvals from “Trusted Regulators”

The MHRA released an update on timing to create an equivalency route for “trusted regulators” such as the US FDA. Find out the timing and plans here.
April 27, 2023

UK MHRA Announcement: New Dates for UK Regulation & CE Marking

The UK MHRA announced new dates to accept CE Marking & for their Medical Device Regulation. Find out the compliance requirements here.
March 28, 2023

UK MHRA to Recognize MDR Transition Extension in Great Britain

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

UK Future Plans: International Agency Recognition, Innovation Routes & Capacity

The UK government released details regarding international recognition with other regulatory agencies (e.g., US FDA) ...
February 20, 2023

MHRA Statement: Impact of the EU Commission’s MDR Extension in the UK

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.