In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
8/25/2025
/ Artificial Intelligence ,
Clinical Trials ,
Cybersecurity ,
Digital Health ,
Environmental Social & Governance (ESG) ,
Genetic Materials ,
Government Agencies ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Supply Chain ,
Trump Administration
On Tuesday 11 March 2025, the European Commission published a legislative proposal for a Critical Medicines Act. The objective of this Act is to ensure stable supply and continuous availability of critical medicinal products,...more
The new Batteries Regulation has passed the final stage of the legislative process and is expected to enter into force soon. The Batteries Regulation is part of the European Green Deal and establishes new technical and legal...more
The European Commission adopted Implementing Regulation (EU) 2021/2226 which establishes the conditions under which instructions for use of certain medical devices subject to the Medical Devices Regulation can be provided in...more
In August 2021, the MDCG issued guidance MDCG 2021-23 for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The...more
Our Medical Device and Technology team has been at the forefront of the COVID-19 legal response since the pandemic swept across the globe. In just a few short months, our team has taken on nearly 200 matters, ranging from...more
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time.
...more
4/21/2020
/ Collaboration ,
Coronavirus/COVID-19 ,
Defense Production Act ,
EU ,
Federal Trade Commission (FTC) ,
Fraud ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Public Health Emergency ,
Supply Chain
On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more
2/7/2019
/ EU ,
Foreign Manufacturers ,
Healthcare ,
Imports ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Sales & Distribution Agreements ,
Supply Chain ,
UK ,
UK Brexit