The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced new steps to reinforce its collaboration with the US Food and Drug Administration (FDA).
Medical Devices
UK PMS Regulations applicable from June 2025
From 16 June 2025, the Medical Devices Post-market Surveillance (PMS) Regulations apply to medical devices and IVDs placed on the market in Great Britain. Published in 2024, the new UK PMS Regulations amends the UK Medical Devices Regulations (MDR) 2002.
MHRA Updates UK Medical Device & IVD Registration Guidance
Discover key insights for placing medical devices on the UK market post-Brexit. Learn about UKCA and CE marking options, appointing a UK Responsible Person, MHRA registration, and regulatory compliance to access the Great Britain market.
Proposed UK regulations on Post Market Surveillance requirements
On 21 October 2024, the UK government laid the Post-market Surveillance (PMS) Statutory Instrument in…
Scotland to ban wet wipes containing plastic
In July 2024, the Scottish Government notified the World Trade Organization (WTO) of a draft…
MHRA Regulatory Strategy on Artificial Intelligence as a medical device
In Spring 2024, the Medicines and Healthcare Products Regulatory Agency (MHRA) unveiled its strategic approach…
New restrictions for cosmetics in the UK
In April, the UK Government announced several changes to the UK Cosmetics Regulation – some…
Digital labels to become reality in the United Kingdom
In January 2024, the United Kingdom announced further measures to ease regulatory obligations for companies.…
UK to align with the latest EU extended provisions: CE-marked devices on the market after 30 June 2023
The United Kingdom is expected to have a revised UK Medical Devices Regulation (MDR) applicable…
MHRA Policy Paper on Medical Technology strategy: a future MedTech landscape for the UK medical sector
Medical technology, also called “MedTech", is a vital part of the healthcare system. It includes…