The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more
8/6/2025
/ Diagnostic Tests ,
EU ,
Health Care Providers ,
International Harmonization ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Regulations ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
UK
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 were officially signed into law on 10 April 2025, marking a significant development in the UK clinical trials framework (the Medicines for Human Use...more
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical device manufacturers understand and prepare for the new post-market surveillance (“PMS”)...more
On 11 December 2024, the MHRA published a revised roadmap for the long-awaited reforms to the UK Medical Device Regulations 2002 (MDR Roadmap). The updated MDR Roadmap provides additional clarity for industry on the intended...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the five technologies selected to participate in the ‘AI Airlock Pilot’ for AI-powered medical devices.
The pilot is a regulatory “sandbox” for...more
On 12 December 2024 the statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK CTR) was laid before Parliament. The Medicines and Healthcare products Regulatory Agency (MHRA),...more
The MHRA has opened a consultation on proposed future pre-market requirements for medical devices and in vitro diagnostic devices (IVDs) in Great Britain. The consultation expands on proposals considered in the MHRA’s 2021...more
The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") has announced first-of-its-kind legislation to better facilitate the manufacture and delivery to patients of medicines that are manufactured at or near the...more
The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") has announced first-of-its-kind legislation to better facilitate the manufacture and delivery to patients of medicines that are manufactured at or near the...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA's) has published a Statement of policy intent: international recognition of medical devices outlining its proposal for the International Recognition Procedure...more
On 30 April 2024, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published its strategic approach to AI and the steps it is taking to implement the UK Government's AI White Paper, published in August 2023....more
Today marks the commencement of the legislation that extends the standstill period for EU CE-marked medical devices to continue to be placed on the market in Great Britain (England, Wales and Scotland)....more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the introduction of new international recognitions routes for the approval of medicines that are already authorised in Australia, Canada, the...more
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an update on the timing of the reform of the current UK legislation, the Medical Device Regulations 2002 (UK MDR), and the transitional arrangements...more
The United Kingdom medical devices regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has announced that the upcoming changes to UK medical device legislation will be pushed back from 1 July 2023 to 1...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to its consultation on the future regulation of medical devices in the United Kingdom which ran between September and November...more
The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published a raft of guidance on how various aspects of the UK regulatory regime for medicines will operate in England, Wales and Scotland (together Great...more
The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ("GB") (England, Wales and Scotland) and in Northern...more
9/25/2020
/ Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
UK ,
UK Brexit
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
3/17/2020
/ Biopharmaceutical ,
Biotechnology ,
Centers for Disease Control and Prevention (CDC) ,
China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Italy ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Netherlands ,
Public Health ,
Reimbursements ,
Research and Development ,
Supply Chain ,
Travel Restrictions ,
Trump Administration ,
UK ,
Vaccinations ,
Vendors ,
World Health Organization
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on the management of clinical trials in the context of coronavirus....more
The Queen's Speech, which set out the government's proposed plan for new legislation, included a new "Medicines and Medical Devices Bill". The government's background briefing describes the purpose of the Bill as ensuring...more
With the possibility of the UK leaving the EU on 29 March 2019 (a "no deal" Brexit) still on the table, life sciences companies are continuing their "no deal" preparations....more
3/21/2019
/ EU ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
No-Deal Brexit ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Standards ,
UK ,
UK Brexit
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...more
1/7/2019
/ Clinical Trials ,
EU ,
Generic Drugs ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
No-Deal Brexit ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Standards ,
UK ,
UK Brexit
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more
10/5/2018
/ Consultation ,
EU ,
European Medicines Agency (EMA) ,
Imports ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agencies ,
Regulatory Oversight ,
UK ,
UK Brexit
The UK government has published several guidance documents on how to prepare for Brexit in the event of a "no deal" scenario (i.e. if the UK and EU do not agree a future trade deal and the proposed post-Brexit...more