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…
The future regulations of medical devices in the United Kingdom
Following Brexit, many changes have been introduced to how medical and in vitro diagnostic devices…
UK and Brexit: towards new Regulations for IVD medical devices
In May 2017, the European Union introduced two new Regulations for medical devices, the Medical…