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…
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…
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…
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.…