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…
Medical Devices
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…
New UK Plastic Packaging Tax effective from April 2022: what manufacturers and importers need to know
Millions of tonnes of plastic waste is produced and imported into the UK every year…
New standards protect UK consumers: what businesses and regulators need to know
A standard can be understood as a harmonised way of doing something. It usually contains…
Updates to the UK Toys & Cosmetics Regulations notified to WTO
On April 13, 2022, the United Kingdom notified the draft “The Toys and Cosmetic Products…
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…