March 28, 2024

Updates: Future UK Regulations, Status of UK International Recognition & IMDRF March Meetings

MHRA updates on the International Recognition Framework (testing progress & timing to publish the outline) and the new draft regulation. Plus, an overview of the IMDRF March meetings.
February 21, 2024

New Association Formed in the UK: Team Approved Body (“Team AB”)

Like Team Notified Body, there is now an association for UK Approved Bodies (“Team AB”). Find out their goals, plus how to find and follow their updates.
January 30, 2024

MHRA Adds Two New UK Approved Bodies: LNE-GMED UK Limited & Scarlet NB UK Ltd

The MHRA newly designated LNE-GMED & Scarlet NB as UK Approved Bodies. Find the list of all Approved Bodies, their scope, and an update on the MHRA's future plans.
January 9, 2024

UK MHRA: 2024-2025 Roadmap of Future Regulatory Framework

The UK MHRA updated the timing and planning for the new medical device and IVD regulation. Click here for the new deadlines, requirements, and link to the roadmap.
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.