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
As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more
4/16/2024
/ Artificial Intelligence ,
Cybersecurity ,
Data Management ,
EU ,
European Parliament ,
General Data Protection Regulation (GDPR) ,
Information Governance ,
International Medical Device Regulators Forum (IMDRF) ,
Life Sciences ,
Machine Learning ,
Med Tech ,
Medical Devices ,
Regulatory Requirements ,
Regulatory Standards ,
Risk Management ,
Technology Sector
HPE Europe is back!
Join the biggest names in healthcare, life sciences and private equity for an unforgettable day of thought-provoking discussions, cutting-edge insights and valuable networking opportunities at the...more
8/16/2023
/ Artificial Intelligence ,
Digital Health ,
Events ,
Health Care Providers ,
Health Information Technologies ,
Health Technology ,
Healthcare Facilities ,
Investment Banks ,
Investment Opportunities ,
Investors ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds
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Draft Guidance ,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
Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...more
9/20/2021
/ Austria ,
Cannabis Products ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Data Protection ,
Denmark ,
Digital Health ,
EU ,
France ,
Germany ,
Healthcare ,
Information Technology ,
Investment ,
Italy ,
Medical Devices ,
Netherlands ,
Pharmaceutical Industry ,
Poland ,
Procurement Guidelines ,
Proposed Legislation ,
Spain ,
Supply Chain ,
Switzerland ,
Telemedicine ,
UK ,
UK Brexit ,
Whistleblowers
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
The Legal Impact in Europe on Pharmaceutical and Medical Device Companies -
The current crisis mode has triggered legal and commercial issues that affect the pharmaceutical and medical device industry across...more
5/27/2020
/ Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
European Competition Network (ECN) ,
Exports ,
Force Majeure Clause ,
Homeland Security Cybersecurity & Infrastructure Security Agency (CISA) ,
Imports ,
Intellectual Property Protection ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Remote Working ,
UK ,
Wine & Alcohol
The impact of Coronavirus (COVID-19) on pharmaceutical and medical device companies has been unique as, not only have these businesses had to set up emergency management systems practically overnight in order to maintain...more
4/2/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Export Bans ,
Medical Devices ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
State of Emergency ,
Supply Chain ,
UK ,
UK Brexit
The UK government has introduced sweeping changes to the UK health legislation as it urgently prepares for the impact of the Coronavirus (COVID-19) pandemic, including increased admissions and demand for intensive care...more
4/1/2020
/ Affiliated-Business Arrangements ,
Business Interruption ,
Coronavirus/COVID-19 ,
Financial Stimulus ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Medical Devices ,
Medical Supplies ,
Relief Measures ,
Small Business ,
Tax Relief
A recent McDermott round table on European health private equity generated key insights into the future of medtech, digital health, and data analytics, and identified opportunities for companies and investors.
Digital...more
12/20/2019
/ CFIUS ,
Digital Health ,
Digital Services Tax ,
Global Dealmaking ,
Healthcare ,
International Arbitration ,
Life Sciences ,
Medical Devices ,
Outbound Transactions ,
Private Equity ,
State-Owned Enterprises ,
UK Competition and Markets Authority (CMA)
The MDR and other recent developments in the health care regulatory landscape pose new opportunities and challenges for medical software companies and investors in digital health in the United Kingdom. Although the regulatory...more
7/3/2019
/ Biotechnology ,
Certification Requirements ,
Code of Conduct ,
Digital Health ,
EU ,
Innovation ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Member State ,
New Regulations ,
No-Deal Brexit ,
Regulatory Oversight ,
UK
Data Inspections in China: Increased Supervision and Compliance -
Data protection inspections have become more frequent for companies with operations in China. Many companies are struggling for guidance on how to...more