Proposed UK regulations on Post Market Surveillance requirements
On 21 October 2024, the UK government laid the Post-market Surveillance (PMS) Statutory Instrument in…
Medical Devices
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…
UK Recognises extended CE Certificates
The UK Government has taken steps towards recognizing extended CE Certificates in light of the…
Approved Bodies for medical devices: UK improving conformity assessment capacity in a post-Brexit landscape
Brexit and the separation of the United Kingdom from the EU have significantly affected a…
Use of CE marking in the United Kingdom: new extensions for manufacturers
The CE marking proves that goods on the EU market meet the applicable regulatory requirements.…