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.…
First UK Approved Body since Brexit to be designated by the MHRA One more step towards a strong UKCA regulatory framework for Medical After the withdrawal of…
New MHRA guidance on software and AI as a medical device change programme Software, Artificial Intelligence (AI) included, plays an increasingly important and crucial role in the health…
A quick dive into GMDN and UDI codes Global Medical Devices Nomenclature (GMDN) is an integral part of the MHRA MD and IVD…