UK post-market surveillance rules for medical devices change in June 2025. Learn what manufacturers must do to stay compliant.
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.
Latest developments on the future of the UK Medical Devices Regulations
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.
Key insights for placing your medical device on the UK market
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…
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…