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,…
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…