The MHRA recently published an update on its plans for MedTech regulatory change. The update confirmed that the new framework will be introduced through four statutory instruments to update and replace the UK Medical Devices...more
On 12 October 2023, the Medicines and Healthcare products Regulatory Agency (the MHRA) announced that the healthcare and life sciences sector will benefit from a new streamlined notification scheme for lowest-risk clinical...more
The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an...more
On Friday 21st October 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to the medical device industry to explain its intention:
- To extend the current standstill period by twelve months from...more
MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION -
The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more
4/29/2022
/ Clinical Trials ,
Data Privacy ,
Data Security ,
Data Transfers ,
Draft Guidance ,
EU ,
General Data Protection Regulation (GDPR) ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Privacy Laws ,
Regulatory Agenda ,
Research and Development ,
UK
The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom), recently announced a consultation to change the UK clinical trial...more
The combination of the Coronavirus (COVID-19) pandemic and the imminent end of the Brexit transition period means a fast-changing regulatory environment for medicines.
On 16 October 2020, the UK Government made changes to...more
10/28/2020
/ Applications ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Exports ,
Imports ,
Licenses ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Regulations ,
UK ,
UK Brexit
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in...more