Good news! The UK government confirmed that the obligation to comply with the UKCA mark…
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…
Is the Irish health sector prepared for an eventual Brexit?
If you are an Irish undertaking producing or exporting medical devices into the European Union…
Obelis UK Ltd established!
We are happy to announce that on 27th of December 2018 Obelis has officially established…