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…
The future of the UK Medical Devices regulatory regime
An insight on the Medicines and Healthcare products Regulatory Agency Delivery Plan 2021-2023 and the…
Update on technical specification for transparent face masks
Since the beginning of the pandemic of Covid-19, the usage of face mask has increased,…
COVID-19 medical devices exceptionally authorised on the UK market: updated list
Due to the COVID-19 outbreak, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has…
COVID-19: specifications for rapid breath tests for detection of SARS-CoV-2 in the UK
Following the Covid-19 crisis and the consequent surge in the demand of Covid test kits,…