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…
Manufacturers to benefit from an indefinite extension of the CE Marking in Great Britain The UK announced today, on 1 August 2023, an indefinite extension of the CE marking…
The UK keeps aligning with the EU – New restrictions for cosmetic substances Since Brexit, the United Kingdom has adopted the same ingredient bans and restrictions as the…
UK Recognises extended CE Certificates The UK Government has taken steps towards recognizing extended CE Certificates in light of the…
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…