January 31, 2023

New UK MHRA Fees Starting April 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

United Kingdom: 2022 Recap & 2023 Look Forward

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

MHRA Guidance: Use of Logo and Registration ‘Endorsement’ Claims

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

Official Announcement: UKCA Marking Postponed & CE Marking Transition Period Extended

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

UK MHRA Updates Vigilance Reporting Process

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.
August 31, 2022

UK MHRA Proposes New Fee Increase

The MHRA issued a consultation to increase fees for medical device clinical investigation notifications and device registrations. Find out the new fees here.
July 27, 2022

EU Commission Launches ‘Northern Ireland Protocol’ Infringements Against UK

The EU issued Northern Ireland Protocol infringements against the UK. The Protocol allows free movement of goods at the UK/EU border in Ireland. Is that now at risk?
July 21, 2022

New UK Regulations: What to Expect and Timeframe to Comply

The MHRA issued an update on the new UK medical device regulation. What will be similar to the MDR/IVDR, what will be different and when does it takes effect?
June 29, 2022

MHRA Announces UKCA Marking to be Postponed: Find Out the New Dates Here

The MHRA released an update to the proposed new UK regulations. It offers further transition period for UKCA marking and longer timeframe to accept CE Marking. Find out more ...