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…
UK to recognize medical devices compliant with EU, US, Australia, and Canada
In May 2024, the United Kingdom government announced the objective to accept medical devices compliant…
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.…
Status of CE and UKCA marking use in the United Kingdom
Since Brexit came into force in 2021, the legislation of the European Union does not…
Implementation status of the future regulatory framework for medical devices
The current regulatory framework for medical devices in Great Britain is the UK MDR. Since…
AI-Airlock regulatory sandbox to support AI medical devices industry
Artificial Intelligence in healthcare is revolutionising the way of diagnosing, treating, and monitoring patients. Its…