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…
Expired certificate in the UK: implication and actions to take
In order to sell medical devices on the UK market, the manufacturer shall register their…
MHRA announces ten principles for medical devices using AI and machine learning technologies
On October 27, 2021, The U.S. Food and Drug Administration (FDA), Health Canada, and the…
Update on Cybersecurity: a new law to protect the user from hacker attacks
A new bill recently came out in the UK to increase data security and safeguard…
Ophthalmological surgeries Handpieces: special points of attention
Are you a manufacturer of medical devices looking to commerce in Great Britain? Check out…
Are the EU Harmonised Standards valid also in the UK?
As of January 1, 2021, the UK has continued to maintain many of the EU…
Compliance of COVID-19 protection equipment in the UK & NI: a brief explanation
CONTEXT: POST-BREXIT COVID-19 UK Taking into consideration the current sanitary situation in Europe and the…