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 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.…
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…