Following the Covid-19 crisis and the consequent surge in the demand of Covid test kits,…
MHRA allows DEHP phthalates in medical devices
Changes are changes, are they not? Brexit being a reality, it can now be presumed…
Free standard & public consultation on community face coverings standard
COVID-19, COVID-19… Needless to say, it is everyone’s duty to tackle and eliminate the virus…
MHRA update to the guidance on the regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with COVID-19
The Medicines and Healthcare products Regulatory Agency (MHRA) is the standalone regulator for medicines and…
What to know about the UKCA marking
On 1 January, 2021, the United Kingdom left the EU Single Market, meaning that goods…
Prosthetic/Orthotic Devices and Ophthalmic products: requirements from the UK MDR
Are you thinking about placing external prostheses and orthoses devices, or even ophthalmic products on…
The UK market after Brexit – The end of grace periods for registering your MDD&IVDs and Cosmetics is approaching quickly
Manufacturers of medical devices, IVDS, and cosmetics, are you aware of the new UK requirements…
Guidance: Regulating medical devices from 1st January 2021 in Great Britain, Northern Ireland and the EU
On 1st September, 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published its latest…
UK’s new dedicated Yellow Card reporting site
The UK is determined to display full information for users of medical devices, and it…
Spanish Agency on labelling of medical device in case of Brexit
The Spanish Agency of Drugs and Medical Devices (AEMPS) has established a transition period until…