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…
All antigen and molecular COVID tests will need to pass validation
On 28 July 2021, the UK government made it a legal requirement to seek validation…
Artificial Intelligence and Software, you are very welcome to Great Britain
Recent events show that the UK is determined to provide its RA regime with an…
UKCA mark requirements postponed! Does it concern your products?
Good news! The UK government confirmed that the obligation to comply with the UKCA mark…