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
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
Health apps and other digital medical devices are making increasingly important contributions to healthcare. While in the past such medical devices were reimbursed by statutory health insurance funds on a case-by-case basis...more
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
3/24/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Exports ,
Germany ,
Market Access Rule ,
Medical Devices ,
Moratorium ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply and Demand
The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more
2/3/2020
/ Cybersecurity ,
EU ,
EU Directive ,
Information Technology ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Standards ,
Risk Assessment ,
Software
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
On May 5, 2017, the new Regulation on Medical Devices (MDR) and the new Regulation on In Vitro Diagnostics (IVDR) have been published in the European Official Journal. The Regulations will become effective 20 days after...more
The European Commission has issued two proposals that, if approved, will fundamentally amend EU law on medical devices and in vitro diagnostics. The proposed legislation will significantly broaden the scope of medical device...more